GB/T 24786: Evolution and historical versions
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Single-use medical poly (vinyl chloride) examination gloves
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GB/T 24786-2025
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| GB 24786-2009 | English | 145 |
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Single-use medical poly (vinyl chloride) examination gloves
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Basic data | Standard ID | GB/T 24786-2025 (GB/T24786-2025) | | Description (Translated English) | Single-use medical poly (vinyl chloride) examination gloves | | Sector / Industry | National Standard (Recommended) | | Date of Implementation | 2026-09-01 | | Older Standard (superseded by this standard) | GB 24786-2009 | GB 24786-2009: Single-use medical poly (vinyl chloride) examination gloves---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Single-use medical poly (vinyl chloride) examination gloves
ICS 11.140; 83.140.99
G45
National Standards of People's Republic of China
PVC single-use medical examination gloves
[ISO 11193-2.2006, Single-usemedicalexaminationgloves-
Part 2. Specificationforglovesmadefromploy (vinylchloride), MOD]
Published 2009-12-15
2010-10-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China issued
Foreword
Chapter 6 of this standard, the content of 8.2 are mandatory, the rest are recommended.
This modified using standard ISO 11193-2.2006 "disposable medical examination gloves Part 2. PVC gloves Specification"
(In English).
This standard is based on ISO 11193-2.2006 redrafted.
The medical examination status of disposable gloves for domestic use PVC production technology, this standard the following technical corrections.
--- The index for single use force at break before and after aging polyvinyl chloride medical exam gloves made 7.0N (see ISO 11193-2.2006
In 6.3.2) to 4.8N (see Table 3).
For ease of use, and the structure of the standard ISO 11193-2.2006 the same, and editorial changes following.
--- deleted the original international standards in the preface;
The term --- "this International Standard" by "this standard";
"." --- replaced by a decimal decimal comma ",";
--- deleted 8.1 "Language for flags shall seek the consensus of interested parties."
Appendix A of this standard is normative.
The standard proposed by China Petroleum and Chemical Industry Association.
The standard rubber and rubber products by the National Technical Committee of Standardization gum Dairy Technical Committee (SAC/TC35/SC4)
Centralized.
This standard was drafted. Shandong Blue Sail Plastic & Rubber Co., Ltd. Rubber Group in Zhuzhou Rubber Plastic Industry Research and Design Institute, Beijing Medical
Spa Device Testing.
Drafters of this standard. Liu Wenjing, Zhang Yongchen, Deng Zhi, Zhang Xiaoli.
PVC single-use medical examination gloves
Warning. The user of this standard should be familiar with general laboratory operations. This standard does not involve any safety issues, even if it is also related
Without exception, the user should establish appropriate safety and health practices, bring it into line with national requirements.
Range 1
This standard specifies a non-sterile or sterile packaged to prevent cross contamination between the patient and the user as a medical examination and diagnosis of
Polyvinyl chloride PVC glove requires the glove or treatment required patients to prevent cross-infection and used, also include a contamination treatment
PVC gloves medical materials.
This standard specifies the requirements and performance examination gloves disposable polyvinyl chloride medical safety, security examination gloves, so that the correct
And with the sterilization process and subsequent processing, packaging and storage processes are not within the scope of this standard.
This standard applies to medical examination, diagnosis or treatment of disease, and treatment of contaminated medical materials disposable polyvinyl chloride medical subject
Charles gloves.
2 Normative references
Terms of the following documents become provisions of this standard by reference in this standard. For dated reference documents, all later
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to agreements based on this standard
Whether the latest versions of these documents. For undated references, the latest version applies to this standard.
Determination GB/T 528, vulcanized or thermoplastic rubber tensile stress-strain properties (GB/T 528-2009, ISO 37.2005,
IDT)
GB/T 2828.1 Sampling procedures - Part 1. Press reception quality limit (the AQL) retrieval-batch inspection sampling plan
(GB/T 2828.1-2003, ISO 2859-1.1999, IDT)
GB/T 2941-2006 rubber physical testing method of preparing a sample and adjust the general procedure (ISO 23529.2004, IDT)
GB/T 3512 Rubber, vulcanized or thermoplastic hot air aging and the accelerated heat resistance test (GB/T 3512-2001,
eqv ISO 188.1998)
GB/T 16886 (all parts) Biological Evaluation of Medical Devices [ISO 10993 (all parts), IDT]
YY0466-2003 medical instruments for medical device labels, signs and symbols providing information (ISO 15223.2000, IDT)
Category 3
Gloves finished divided into the following types.
a) partially or anesthesia glove surface;
b) Smooth gloves;
c) there is powder-free gloves;
d) powder-free gloves.
Note 1. Powdered gloves are worn for ease of powder added in the manufacturing process; powder-free gloves during the manufacturing process is not intentionally added powder material.
Note 2. The glove cuffs may be a regular straight cut edge, and may be rolled rounded edges.
4 Materials
This standard relates to the glove material should be polyvinyl chloride, for ease worn can surface treatment agent, a lubricant, a powder or a poly
Together paint.
Any of a pigment, a surface treating agent, a lubricant or a powder material should be non-toxic, and should require disclosure. For the surface treatment composition may be removed
Quality should be bioabsorbable.
Gloves should be provided to users meet the requirements of GB/T 16886-concerned. When necessary, the manufacturer should be easy to get in line with buyers
Information on these requirements.
NOTE. The existing relevant national or industry standard test methods, after the release of this standard may be specified in the glove extractable plasticizer, and residual compounds
Limited residual powder.
Sampling and test piece 5 selected
5.1 Sampling
As the purpose of arbitration, gloves should GB/T 2828.1 requirements for sampling and inspection, inspection level and the reception quality limit (the AQL)
Shall comply with the provisions in Table 1.
When the batch size can not be determined, it should be assumed in quantities of 35,001 to 150,000.
Table 1 checks the reception level and quality limit (the AQL)
Characteristics inspection level AQL
Dimensions (width, length, thickness) S-2 4.0
Water impermeability Ⅰ 2.5
Force at break and elongation at break S-2 4.0
5.2 Select test strip
Test strip should glove finger along the palm or back clipping direction.
6.1 size
By measuring the position shown in Figure 1, the glove palm width and length shall be as specified in Table 2, and checks the reception quality threshold level (the AQL) see
Table 1.
Length should be the shortest distance from the top edge of the middle finger to the cuff.
Note. the length measurement can be hung on the top of the glove were measured on a radius of 5mm suitable rod.
Measuring the width of the root to the root of the index finger should be neutral position thumb measured. When measuring, gloves should be flat.
Glove double thickness measurement should be GB/T 2941-2006, and having a pressure sufficient measure of 22kPa ± 5kPa, in FIG. 2
Each position measurement shown, namely. from the middle finger ± 3mm and about 13mm at the palm of the glove. Bilayer thickness of each point measured
Referred to as a half of the thickness of a single layer. Size shall be as specified in Table 2, and checks the reception quality threshold level (the AQL) should meet the requirements of Table 1.
If the visual examination revealed the presence of thin spots, monolayer thickness should be measured at these sites thin spots. Ma monolayers thick and glossy surface portion
When the measurement by the provision, ratio not less than 0.08mm and 0.11mm.
Note. The thickness of the glove cuffs press GB/T 2941-2006 assay, preferably not more than 2.50mm.
---width.
A length and width of the measurement position of FIG.
In millimeters
Note. For different sizes of gloves, 48mm ± 9mm position about the center position in the palm of your hand.
FIG thickness measurement positions 2
Table 2 dimensions and tolerances
specification
width
(Size, FIG. 1)
mm
specification
(small Medium Large)
Nominal width
(Size, FIG. 1)
mm
Minimum length
mm
Minimum thickness
(FIG. 2)
mm
The maximum thickness
(Approximately in the center of the palm)
mm
6 and below ≤82
6 83 ± 5
7 89 ± 5
7 95 ± 5
8 102 ± 6
8 109 ± 6
9 and above ≥110
Laid small (X-S) ≤80
Small (S) 80 ± 10
In (M) 95 ± 10
Large (L) 110 ± 10
King (X-L) ≥110
Smooth area. 0.08
Ma surface area. 0.11
Smooth area. 0.22
Ma surface area. 0.23
6.2 impermeability
When tested according to the water-impermeable gloves Appendix A, which allows the sample size and the number of defective (leak) of the glove, should be in accordance with Table 1
The check level and the reception quality limit (the AQL) is determined.
6.3 Tensile properties
6.3.1 Overview
Tensile properties shall GB/T 528 is measured, taking three test pieces cut from each glove, the results were the median.
Force at break before aging 6.3.2 and elongation at break
When measured according to the test methods specified in GB/T 528, using 2 dumbbell type test pieces, tensile strength and elongation at break should be consistent with Table 3
Predetermined, and checks the reception quality threshold level (the AQL) should meet the requirements of Table 1.
Table 3 Tensile Properties
Performance requirements
The minimum force at break before aging/N 4.8
Elongation at break before aging min/350%
After aging tearing Min/N 4.8
Minimum elongation at break after aging/350%
6.3.3 aging tearing and elongation at break
Aging Test Method should be GB/T 3512 is predetermined. After the sample from (70 ± 2) ℃, (168 ± 2) h after aging gloves
After clipping, the test piece may be cut taken from the glove, then aging under the above conditions, a tensile test was carried out 6.3.2.
6.4 Sterilization
Sterile gloves should be required to identify the type of glove sterilization process.
7 Packaging
If the gloves are sterile, they should be only a single package or a twin pack.
8 logo
8.1 Overview
Flag accordance with the requirements specified in this standard, YY0466-2003 Suitable symbols are available on the label.
8.2 Packaging Unit
Single glove or a pair of gloves into the bag is the unit packaging.
8.2.1 Sterilization Packaging
Sterilization packaging should be clearly marked with the following.
a) the name or trademark of the manufacturer or supplier;
b) the materials used;
C) "Pits", "glossy", "Powdered", "powder-free" or have this effect on the finished glove words;
d) specification;
e) Once the glove material treated with any surface, the warning should be sterile and should be removed prior to use surface of the powder;
f) identifying the manufacturer's lot number;
g) "date of manufacture" or similar words, the year (four digits) and month of manufacture;
h) "sterile unless package is opened or destroyed" in the words;
i) "examination gloves" words;
j) the word "single-use" message or the same meaning;
K) "contained in the product may be hazardous to the user plasticizer (plasticizer properties to be disclosed)" message.
8.2.2 Non-sterile packaging
Non-sterile packaging should be clearly marked with the following.
a) the name or trademark of the manufacturer or supplier;
b) the materials used;
C) "Pits", "glossy", "Powdered", "powder-free" or have this effect on the finished glove words;
d) specification;
e) identifying the manufacturer's lot number;
F) "single use" or words to the same meaning;
G) "non-sterile";
h) "examination gloves" words;
i) "date of manufacture" or similar words, the year (four digits) and month of manufacture;
J) "contained in the product may be hazardous to the user plasticizer (plasticizer properties to be disclosed)" message.
More than 8.3 units of packaging
Multi-unit package is equivalent to a predetermined number of the same size gloves (packed or unpacked unit) of a box of products, its purpose is it
For safe transport and storage. Multi-unit packaging should be labeled 8.2.1 and 8.2.2, and shall indicate the number of gloves and additional storage instructions.
Appendix A
(Normative)
Impermeability
A. 1 device
A. 1.1 a cylindrical barrel
Minimum diameter of 60mm, that can accommodate water 1000mL, and has sufficient length for fixing gloves, A. FIG. 1 shown in FIG.
Note. cylindrical tube is preferably transparent.
A. 1.2 fixture
Water-filled glove should be held vertically, as shown in A. 2 shown in FIG.
A. Cylindrical measuring 1.3
1000mL 1000mL water or volume of at least one-time transfer apparatus.
A. Step 2
By suitable means, such as an O-ring, the glove is fixed to the cylinder barrel, so that the glove does not exceed the cylinder barrel 40mm.
Introducing 1000mL ± 50mL, not more than 36 ℃ water into the device, wipe off any water splashed on the glove. If the water does not rise
From the edge of the sleeve 40mm, hold up the whole glove gloves cuff from part other than 40mm are filled with water. Now pay attention to any apparent infiltration
leak. If the glove does not leak immediately, and then observed 2min ~ 4min. Ignore leakage from the sleeve edges within 40mm. For ease of observation, can be
Dyed with water-soluble dye.
In millimeters
1 --- hook;
2 --- cylinder barrel;
Reticle inner surface of the cylinder barrel 3 ---.
Figure A. A cylinder barrel
Book GB 24786-2009
Figure A. Fixing means 2
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