FDA 510(k)

POWDER-FREE PATIENT EXAMINATION GLOVES

K-Number: K971949 · 1997-07-28

Decision Date1997-07-28

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Tekmedic (M) Sdn Bhd. It received FDA 510(k) clearance on 1997-07-28 under 510(k) number K971949. 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 POWDER-FREE PATIENT EXAMINATION GLOVES?

POWDER-FREE PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 1997-07-28. The listed applicant is Tekmedic (M) Sdn Bhd. The 510(k) number is K971949.

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

POWDER-FREE PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 1997-07-28, under 510(k) number K971949.

Who is the listed applicant for POWDER-FREE PATIENT EXAMINATION GLOVES?

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

What is the FDA product code for POWDER-FREE PATIENT EXAMINATION GLOVES?

The FDA product code for POWDER-FREE PATIENT EXAMINATION GLOVES is LYY.

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Other records listing Tekmedic (M) Sdn Bhd as applicant

K121592POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS K121594COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)K121591FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)K121192NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN K013317TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

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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.