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FDA 510(k)

DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT

K-Number: K032016 · 2004-05-11

ApplicantWrp Specialty Products Sdn. Bhd.
Decision Date2004-05-11
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Specialty Products Sdn. Bhd.. It received FDA 510(k) clearance on 2004-05-11 under 510(k) number K032016. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT?

DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT is a medical device that received FDA 510(k) clearance on 2004-05-11. The listed applicant is Wrp Specialty Products Sdn. Bhd.. The 510(k) number is K032016.

When did DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT receive FDA 510(k) clearance?

DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT received FDA 510(k) clearance on 2004-05-11, under 510(k) number K032016.

Who is the listed applicant for DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT?

The FDA 510(k) record lists Wrp Specialty Products Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT?

The FDA product code for DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT is LYY.

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Other records listing Wrp Specialty Products Sdn. Bhd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022808DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 UG OR LESS)K021561DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OK021536DERMAGRIP AND MULTIPLE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRK021396DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILEK014288DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORSK013942POWDER FREE BLUE LATEX EXAMINATION GLOVE, NON-STERILE (PROTEIN CONTENT LABELING)

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Related Devices (Code: LYY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company LimitedK230573Powder 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)Kossan International Sdn BhdK223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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