ESound Med

Disposable Sterile Latex Surgical Gloves ESound Med

Textured surface with powdered;
Textured surface with powder free;
Smooth Surface with powdered;
Smooth Surface with powder free;
straight curved

[Product]: Disposable Sterile Latex Surgical Gloves [Types and Size]:
Types:Straight Fingers (Textured & Powdered, Textured & Powder-Free, Smooth & Powdered,
Smooth & Powder-Free)
Curved Fingers (Textured & Powdered, Textured & Powder-Free, Smooth & Powdered,
Smooth & Powder-Free)
Size Codes: 5#, 5.5#, 6#, 6.5#, 7#, 7.5#, 8#, 8.5#, 9#, 9.5#
[Production License Number]:No. 20160050 of Henan Food and Drug Administration Production License
[Registration Number]: Henan Medical Device Registration Certificate 20182660199
[Product Technical Requirement Number]: Henan Medical Device Registration Certificate 20182660199
[Indications]: Applied to Provide Protection in Clinical Surgery.
[Structure and Components]: This Product is Made of Natural Rubber Latex by Machine.
[Performance]:
1. Dimensions: When the Measurement is Conducted According to the Position Shown in Figure 1 of GB7543-2006 Standard, the Width, Thickness and Length of the Gloves Shall Meet the Requirements Specified in Table 2 of GB7543-2006 Standard, and the Inspection Level and Acceptance Quality Limit (AQL) Shall Be in Accordance With the Requirements Specified in Table 1 of GB7543-2006 Standard.
2. Impermeability: When Water Impermeability Test According to Appendix A of GB7543-
2006 Standard is Conducted, the Sample Size and Allowable Number of Unqualified (Permeable) Gloves Shall be Determined According to the Inspection Level and Acceptance Quality Limit (AQL) in Table 1 of GB7543-2006 Standard.
3. Tensile Performance: The Tensile Performance of the Gloves Shall Meet the Requirements Specified in Table 3 of GB7543-2006 Standard Before and After Aging.
4. The Gloves Should be Sterile.
5. Ethylene Oxide Residue: The Ethylene Oxide Residue Shall Not Exceed 10μg/g After Ethylene Oxide Sterilization.
6. Double Packaging.
7. Signs:
7.1. The Inner Packaging Shall Meet the Requirements Specified in 8.2 of GB 10213-2006 Standard.
7.2. Single-unit Packaging Shall Meet the Requirements Specified in 8.3 of GB 10213-2006 Standard.
7.3. Multi-unit Packaging Shall Meet the Requirements Specified in 8.4 of GB 10213-2006 Standard.
[Directions for Use]:
1. Check the External Packaging Before Donning and Immediately Discontinue Use If the Product is Found Damaged.
2. Take Out the Surgical 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]: May 1st, 2018

size

XS (6# and below 6#L),S (6.5#), M (7#. 7.5#),L(8#, 8.5#), XL (9# and above 9#)

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