FDA 510(k)

PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE)

K-Number: K954081 · 1995-10-30

ApplicantTan Chong Rubber Gloves Sdn Bhd

Decision Date1995-10-30

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Tan Chong Rubber Gloves Sdn Bhd. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K954081. 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 (NON-CHLORINATED POWDER FREE, NON-STERILE)?

PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Tan Chong Rubber Gloves Sdn Bhd. The 510(k) number is K954081.

When did PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) receive FDA 510(k) clearance?

PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) received FDA 510(k) clearance on 1995-10-30, under 510(k) number K954081.

Who is the listed applicant for PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE)?

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

What is the FDA product code for PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE)?

The FDA product code for PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE) is LYY.

Related Clinical Trials

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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Other records listing Tan Chong Rubber Gloves Sdn Bhd as applicant

K891501PATIENT EXAMINATION GLOVES (LATEX)

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.