FDA 510(k)

STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'

K-Number: K895807 · 1989-12-18

Decision Date1989-12-18

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' is the device name listed in this FDA 510(k) record. The listed applicant is Safeskin Corp.. It received FDA 510(k) clearance on 1989-12-18 under 510(k) number K895807. 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 STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'?

STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' is a medical device that received FDA 510(k) clearance on 1989-12-18. The listed applicant is Safeskin Corp.. The 510(k) number is K895807.

When did STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' receive FDA 510(k) clearance?

STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' received FDA 510(k) clearance on 1989-12-18, under 510(k) number K895807.

Who is the listed applicant for STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'?

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

What is the FDA product code for STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'?

The FDA product code for STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' is LYY.

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Other records listing Safeskin Corp. as applicant

K993117SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG K994081SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES K992830SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE K992210SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES K992162SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM K992062SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES

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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.