DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT— 510(k) K032016

Clearance details

Applicant

Wrp Specialty Products Sdn. Bhd.

Product code

Code LYY

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2003-06-30

Decision date

2004-05-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tinggi, Sepang, Selangor, MY

• K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein2025-04-29
• K240266 — Latex Examination Glove Powder Free (Ocean Blue and Natural White)2024-09-09
• K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)2023-06-13
• K223298 — Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)2023-02-22
• K222612 — Powder-Free Latex examination gloves2022-11-25

• K022808 — DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)2002-10-03
• K021561 — DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM O2002-06-11
• K021536 — DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGR2002-06-10
• K021396 — DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE2002-05-16
• K014288 — DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS2002-02-13