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FDA 510(k)

DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI

K-Number: K040645 · 2004-04-28

ApplicantWrp Asia Pacific Sdn. Bhd.
Decision Date2004-04-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2004-04-28 under 510(k) number K040645. 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-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI?

DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K040645.

When did DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI receive FDA 510(k) clearance?

DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI received FDA 510(k) clearance on 2004-04-28, under 510(k) number K040645.

Who is the listed applicant for DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI?

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

What is the FDA product code for DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI?

The FDA product code for DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI is LYY.

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Other records listing Wrp Asia Pacific 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.

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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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