FDA 510(k)

PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

K-Number: K954415 · 1996-03-12

Decision Date1996-03-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Hartalega Sdn Bhd. It received FDA 510(k) clearance on 1996-03-12 under 510(k) number K954415. 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 PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM?

PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM is a medical device that received FDA 510(k) clearance on 1996-03-12. The listed applicant is Hartalega Sdn Bhd. The 510(k) number is K954415.

When did PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM receive FDA 510(k) clearance?

PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM received FDA 510(k) clearance on 1996-03-12, under 510(k) number K954415.

Who is the listed applicant for PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM?

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

What is the FDA product code for PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM?

The FDA product code for PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM is LYY.

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Other records listing Hartalega Sdn Bhd as applicant

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Related Devices (Code: LYY)

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 Limited K230573Powder 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 Bhd K223298Sterile 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

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