FDA 510(k)

HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)

K-Number: K973801 · 1997-11-21

Decision Date1997-11-21

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) is the device name listed in this FDA 510(k) record. The listed applicant is Sri Johani Sdn. Bhd.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973801. 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 HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)?

HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Sri Johani Sdn. Bhd.. The 510(k) number is K973801.

When did HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) receive FDA 510(k) clearance?

HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973801.

Who is the listed applicant for HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)?

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

What is the FDA product code for HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)?

The FDA product code for HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR) is LYY.

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Other records listing Sri Johani Sdn. Bhd. as applicant

K993454POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)K993457POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]K993458POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)K981039POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)K980039POWDERED GREEN LATEX EXAMINATION GLOVES K980038POWDERFREE GREEN LATEX 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.