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FDA 510(k)

COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN

K-Number: K100694 · 2010-06-25

ApplicantTekmedic (M) Sdn Bhd
Decision Date2010-06-25
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN 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 2010-06-25 under 510(k) number K100694. 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 COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN?

COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is Tekmedic (M) Sdn Bhd. The 510(k) number is K100694.

When did COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN receive FDA 510(k) clearance?

COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN received FDA 510(k) clearance on 2010-06-25, under 510(k) number K100694.

Who is the listed applicant for COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN?

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 COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN?

The FDA product code for COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN is LYY.

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Other records listing Tekmedic (M) Sdn Bhd as applicant

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.

K121592POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGSK121594COLORED 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)K013317TEKMEDIC POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)K000555TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O

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Related Devices (Code: LYY)

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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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.

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