FDA 510(k)

SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES

K-Number: K914276 · 1992-12-04

Decision Date1992-12-04

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Sime Health, Ltd.. It received FDA 510(k) clearance on 1992-12-04 under 510(k) number K914276. 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 SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES?

SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1992-12-04. The listed applicant is Sime Health, Ltd.. The 510(k) number is K914276.

When did SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES receive FDA 510(k) clearance?

SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES received FDA 510(k) clearance on 1992-12-04, under 510(k) number K914276.

Who is the listed applicant for SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES?

The FDA 510(k) record lists Sime Health, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES?

The FDA product code for SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES is LYY.

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Other records listing Sime Health, Ltd. as applicant

K954051SIME POWDERFREE PLUS K954025SIME SURGICAL POWDERFREE K932985AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI K932982SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932983COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)K932984UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI

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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.