This standard specifies the technical requirements, sampling inspection methods, test methods, packaging, marking and storage of examination gloves made of natural rubber latex. This standard applies to examination gloves used for medical examination, health protection and other purposes. GB 10213-1995 Disposable rubber examination gloves GB10213-1995 Standard download and decompression password: www.bzxz.net

1 scope
National Standard of the People's Republic of China
Disposable rubber examination gloves
Singie-use rubber
examination glove--SpecificationGB10213-1995
replacement GB10213-88
This standard specifies the technical requirements, sampling inspection methods, test methods, packaging, marking and storage of examination gloves made of natural rubber latex.
This standard applies to examination gloves used for medical examination, health protection and other purposes. Referenced standards
2
The following standards contain provisions that constitute provisions of this standard through reference in this standard. The editions shown were valid at the time of publication of the standard. All standards are subject to revision and parties using this standard should explore the possibility of using the latest version of the standard listed below. GB/T528-92 Determination of tensile properties of vulcanized rubber and thermoplastic rubber GB2828-87 Batch-by-batch inspection and counting sampling procedures and sampling tables (adapted to inspection of continuous batches) GB/T3512--83 (89) Rubber hot air aging test method (neqISO188 :1976) GB/T5723-93 Determination of dimensions of test specimens and products for vulcanized rubber or thermoplastic rubber (eqVISO4648:1991) 3 Material
Gloves should be made of natural rubber latex. Any materials used should be safe and harmless. Any surface treatment that facilitates wearing gloves, such as powder release agents and lubricants, should be stated as required. Any surface treatment should be bioabsorbable. 4 Design
4.1 Sleeve edges
The sleeve edges should be of appropriate elasticity and should not have any rollback or wrinkles during use. 5 Sampling and sample selection
5.1 Sampling
Sampling inspection of gloves should be carried out in accordance with GB2828. The inspection quality and acceptable quality level (AQL) should comply with the provisions of Table 1. Note: The parties concerned can coordinate the use of more stringent inspection levels and AQL. Table 1 Inspection level and AQL
Performance
Performance
Physical dimensions (length, width, thickness)
Water leakage
Tensile strength and tear-off Elongation (before and after aging) inspection level
S-2
S-4
S-2
When the inspection results of each batch of products do not exceed the requirements in Table 3 When the AQL is reached, the batch of products is a qualified batch. State Bureau of Technical Supervision approved AQL
4.0
2.5
4.0
1996-08-01 on 1995-12-20
63||tt| |GB10213—1995
When any item of the inspection results of each batch of products exceeds the AQL specified in Table 3, the unqualified items will be strictly inspected once. If they are qualified
, it will be judged as a qualified batch , if it fails, it will be judged as a failed batch. 5.2 Selection of specimens
Using the H-type cutter specified in GB/T528, it should be possible to cut the specimen from the palm of an unused glove, and patterned areas should be avoided. 6 Requirements
6.1
Physical dimensions
When measured at the position shown in Figure 1, the size of the gloves should comply with the provisions of Table 2, and the inspection level and AQL value should comply with the provisions of Table 1 . Fingertip
Width Out
Picture 1 Measurement Position
Table 2 Dimensions and Tolerances
Name
Palm
Weight||tt| |Width
Degree
Length
Single layer thickness of palm or finger
Small
80
No.
Medium| |tt||95
230
0.08
Distance
Palm
mmbzxZ.net
413±3
B33 ±5
W/2±5
edge
mm
big
110
public
difference| | tt | Half of the double thickness is recorded as the single layer thickness.
6.2 Water leakage test
When the water leakage test is performed according to Appendix A, the gloves should not leak. The inspection level and AQL should comply with the requirements in Table 1. 6.3 Tensile properties
6.3.1 Tensile properties before aging should be carried out in accordance with GB/T528. 6.3.2 The thermal aging test shall be carried out in accordance with GB/T3512. And do it every half month. The aging test can be carried out according to the following conditions: 1 70℃±2℃
2 100℃±2℃
64
166h±2h
22h±0.3 h
The arbitration test is: 70℃±2℃
property
GB 10213—1995
166h±2h
energy
aging Minimum tensile strength before aging, MPa
Minimum elongation at break before aging, %
Minimum tensile strength after aging, MPa
Minimum elongation at break after aging, %
Table 3 Tensile Properties
Ask
21
700
16
500
Ask||tt| |6.3.3 The tensile properties before and after aging should comply with the provisions of Table 3, and the inspection level and AQL are as shown in Table 1. If a sample needs to be cut from the glove pattern area, its test value can be 10% lower than the value specified in Table 3. 6.4 If gloves are provided sterilized, the sterilization method should be stated as required. 7 Packaging and marking
Requirements for packaging materials
7.11
All packaging materials should have sufficient strength and not contain substances harmful to the quality of gloves and users, so that they can be used during normal use No harm to the user.
7.2 Sterile packaging and marking
7.2.1 Unit packaging
One or a pair of hands placed in a seal or envelope is a unit package. The unit packaging should be marked with the following: a) Manufacturer’s name and registered trademark;
b) Product name and specifications:
c) Manufacturing date or production batch number;
d) “Unless Opened or damaged, this package is sterile packaging", e) "single use".
7.2.2 Medium packaging
Packaging several units of the same specifications into one box is called medium packaging. The following contents should be marked on the middle package: a) Manufacturing name and registered trademark:
b) Product name and specifications;
c) Manufacturing date or production batch number:
d) Inner gloves Quantity;
e) Standard code;
f) "One-time use".
7.2.3 Outer packaging
Putting several intermediate packages of the same specifications into one box is the outer packaging. The outer packaging should be marked with the following: a) manufacturer name and registered trademark;
b) product name and specifications;
c) manufacturing date or production batch number;
d) inner gloves Quantity;
e) Sterilization method, time and validity period; f) Marking code;
g) "--single use";
h) Size of outer packaging and weight.
7.3 Non-sterile packaging and marking
65
7.3.1 Inner packaging
GB 10213--1995
Specified quantity of the same specifications The set comes in one bag, which is the inner packaging. The inner packaging should be marked with the following: a) manufacturer name and registered trademark;
b) product name and specifications;
c) manufacturing date or production batch number;
d) inner gloves Quantity;
e) Standard code;
f) "One-time use".
7.3.2 Outer packaging
Putting several inner packages of the same specifications into one box is called outer packaging. The outer packaging should be marked with the following: a) Manufacturer’s name and registered trademark;
b) Product name and specifications:
c) Manufacturing date or production batch number;
d) Inner gloves Quantity;
e) Standard code;
f) "One-time use";
g) Size and weight of outer packaging.
8 Transportation and Storage
8.1 Gloves must be covered during transportation and placed in a dry place, away from moisture and heat. 8.2. Gloves should be stored in a well-ventilated, cool and dry warehouse (the indoor temperature should be below 30°C and the relative humidity below 80% is appropriate). They should be placed on shelves 200mm above the ground. They should avoid direct exposure to strong artificial light from sunlight or ultraviolet components. , there is no device that generates ozone in the warehouse.
8.3 Gloves must not come into contact with oil, acid, alkali, copper, manganese and other harmful dry rubber substances during storage. 8.4 The storage period of gloves is 18 months from the date of manufacture. 66
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