ESound Med

ESound Med Latex Sterile or non-sterile Examination Gloves

Textured surface powdered
Textured surface powder free
Smooth Surface powdered
Smooth Surface powder free
Feature
Made of 100% natural latex

[Product]: Disposable Medical Exam Latex Gloves [Types and Specifications]:
Types: Textured & Powdered, Textured & Powder-Free, Smooth & Powdered, Smooth & Powder-Free
Size Code: Extra Small (6# and smaller), Small (6.5#),Medium (7.0#,7.5#),
Large (8#, 8.5#), Extra Large (9# and Larger)
[Production License Number]: No. 20160050 of Henan Food and Drug Administration Production License
[Registration Number]: Henan Medical Device Registration Certificate 20182660200
[Product Technical Requirement Number]: Henan Medical Device Registration Certificate 20182660200
[Indications]: Applied to Prevent Cross Infection Between Doctors and Patients.
[Structure and Components]: This Product is Made of Natural Rubber Latex by Machine.
[Performance]:
1. Dimensions: When Measured According to the Position Shown in Figure 1 of GB10213-2006 Standard, the Width, Thickness and Length of Gloves Shall Comply With the Requirements Specified in Table 2, and the Inspection Level and Acceptable Quality Limit (AQL) Shall Be in Accordance With the Requirements Specified in Table 1.
2. Impermeability: When the Water Impermeability Test According to Appendix A of GB10213-2006 Standard is Conducted, the Sample Size and the Number of Allowed Unqualified (Permeable) Gloves Shall be Determined According to the Inspection Level and Acceptance Quality Limit (AQL) Specified in Table 1.
3. Tensile Performance:
3.1. Breaking Tenacity and Elongation Before aging: When Tested with Type 2 Dumbbell Specimens According to the Test Method Specified in ISO37, the Breaking Tenacity and Elongation at Break Shall Meet the Requirements Specified in Table 3 of GB10213-2006 Standard, and the Inspection Level and Acceptance Quality Limit (AQL) Shall Meet the Requirements Specified in Table 1.
3.2. Breaking Tenacity and Elongation After Aging: The Thermal Aging Test Shall Be Conducted According to the Method Specified in ISO188 by Aging the Specimens Cut From the Gloves for 168h ± 2H Under the Temperature of 70℃±2℃(158℉±35.6 ℉), and the Breaking Tenacity and Elongation at Break Shall Meet the Requirements Specified in Table 3 of GB10213-2006 Standard, and the Inspection Level and Acceptance Quality Limit (AQL) Shall Meet the Requirements Specified in Table 1.
4. Medical Exam Latex Gloves Should Be Sterile.
5. Ethylene Oxide Residue: The Ethylene Oxide Residue Shall Not Exceed 10μg/g after Ethylene Oxide Sterilization.
6. Packaging: If the Medical Latex Gloves are Sterile, They Shall Be Packed Separately or Packed with Pair as Packing Unit.
7. Signs: Single-unit Packaging Shall Comply With the Requirements Specified in 8.2 of GB 10213-2006 Standard. Multi-unit Packaging shall Comply With the Requirements Specified in 8.3 of GB 10213-2006 Standard.
[Directions for Use]:
1. Check the External Packaging Before Donning and Immediate Discontinue Use If Found Damaged.
2. Take Out the Medical Exam Gloves and Don Them Properly.
[Storage]: Store in a Dry and Clean Warehouse with Excellent Ventilation and No Corrosive Gas Where the Relative Humidity is Less than 80%.
[Batch Number]: On the Package Bag.
[Production Date]: On the Package Bag.
[Date of Expiry]: On the Package Bag.
[Contraindications]: If You are Allergic to the Natural Rubber Latex, Consult Your Physician Before Use.
[Cautions]:
1. After Ethylene Oxide Sterilization, the Sterility Remains Valid for Two Years.
2. The Date of Sterilization is Printed On the External Package Box.
3. Do Not Use the Products Beyond the Expiration Date of Sterility.
4. Do Not Use If Package is Damaged.
5. This Product is Disposable. Dispose After Single Use.
6. Remove Powder From Gloves with Wet Sterile Gauze or Other Methods Before Use (Only For Powered Gloves).

Single Use Only Sterile Ethylene Oxide Sterilization Cautions

[Registrant Name]: ESound Medical Device Co., Ltd.
[Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Contact]: 0373-7152666
[After-Sales Service Unit]: ESound Medical Device Co., Ltd.
[Registrant Organization]: ESound Medical Device Co., Ltd.
[Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Production Address]: High-Tech Medical Device Industrial Park, Changyuan County
[Contact]: 0373-7152666
[Date of Compilation]: April 28th, 2018

size

S, M, L, XL

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