PRODUCT : LATEX POWDER FREE GLOVES

Medical Grade, Non-sterile and Non-medical Grade, Non-sterile

Powder Free (Chlorinated Online) Gloves

Palm Texture & Full y Glazed Smooth Surface

INTENDED USED

Medical Grade Gloves: Medical activities (except surgery) to reduce contamination between patient and examiner where powder free glove chlorinated, Natural Latex is acceptable.

Non-medical Grade Glove: non-medical activities to reduce contamination between user and things where powder fee glove chlorinated, Natural Latex are acceptable.

MATERIAL

Natural Rubber Latex

OUTER SURFACE

Halogenaiton iliconization and Extensive Washing in Water

Non-donning powder used

COMPONENTS

Natural Rubber Latex

Sulfur, Zinc Oxidize

Organic Accelerators

Dithiocarbamates

SHAPE

Ambidextrous, straight fingers, thumb and fingers in on plane

Bead Cuff (roll rim)

COLOR : Natural (light yellowish, white)

SIZE : Extra Small (XS), Small (S), Medium (M), Large(L), Extra-large (XL)

MARKING : Gloves are not marked to designed size. Interior boxes are size specific and marked on box.

PACKING AND LABEL : 100 pieces per box, 10 boxes per case, 1000 pieces per case

CONTROL NUMBER (LOT NO.) : Each packing unit (dispenser box) and outer carton bears a Control Number / Lot Number.

Lot number shall be marked as DDDYXPP, where:

+ DDD: running number of the packing date according to Julian date (365 days in a year), e.g. the date 31/01 shall be 031; the date 02/02 shall be 033...

+ Y: the last number of the year, e.g.: year 2009 shall be marked as 9

+ X: size mark, XS: 0; S: 1; M: 2; L: 3; XL: 4.

+ PP: ordering number of the pallet and starts from 01.

Example: 0319101 (Date: 31/01, Year: 2009, Size: Small, Pallet No.: 01)

PERFORMANCE REQUIREMENT FOR QUALITY CHARACTERICTICS

For reference purpose in accordance with ISO 2859 (Sampling Procedure for Inspection by Attributes US Pharmacopoeia)

INTERNAL ATTRIBITIVE RELEASE INSPECTION

Sampling examination in accordance with ISO 2859

Unit for inspection: one (1) glove

If several defects are found down on one glove, only the most serious defect (i.e. lowest category) is evaluated.

The acceptable criteria is based on the number of defectives observed in a sample

 FINAL GLOVE RELEASE

Assurance action:

ASTM D 3578: Standard Specification for Rubber Examination Gloves

ASTM D 5151: Standard Test Method for Detection of Holes in Medical Gloves

Sampling inspection and final release information

Major defects: highest concern non-conformities which prevent correct use of product.

AQL 1.5 (inspection level GI for leaks)

Minor defects: non-conformities of a lesser degree concern, which do not prevent correct use of the product. AQL 4.0 (inspection level GI for visual defect aggregated)

 

PACKING, MARKING, GOODS DELVERY INSPECTION

Assurance action:

Set-up and patrol inspection at packing: QC visual checking, QA reshipment Supervision of vehicle, vessel loading 

Compliance with C-TPAT (US Custom-Trade Partnership against Terrorism)

GOOD MANUFACTURING PRACTICE

The gloves are manufacturing in compliance with I SO 9001, Medical Device 13458

CAUTION

This glove contains natural rubber latex that may cause adverse allergic reactions to users. I t has been reported that 6% to 7 % of all health care personnel are latex sensitive. Immediately discontinue use when reddening or irritation occurs. Users who are sensitive to latex and / or chemicals should consider other alternative hand protections like vinyl gloves or consults physicians before using. Safe use of this glove by or on latex sensitive individuals has not been established.

Non-sterile examination gloves are used in a variety of circumstances, including procedures where the surface of the glove contacts wounds, body cavities, or other possible routes of contamination. If condition warrant, the user may wish to minimize of the risk of infection. In this case, we recommend the decontamination of gloves prior to use by disinfectants or other effective methods

STORAGE

Store in a dry, ventilated area

Avoid direct sunlight, fluorescent lighting, and storage to photocopy equipments, heat, and moisture.

Do not store above 100oF (38oC) as this will lead to accelerated aging

Long-term storage can result in pleats, stickiness, and earl y aging of the gloves

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