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FDA 510(k)

NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)

K-Number: K121192 · 2012-08-03

ApplicantTekmedic (M) Sdn Bhd
Decision Date2012-08-03
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) 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 2012-08-03 under 510(k) number K121192. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)?

NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) is a medical device that received FDA 510(k) clearance on 2012-08-03. The listed applicant is Tekmedic (M) Sdn Bhd. The 510(k) number is K121192.

When did NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) receive FDA 510(k) clearance?

NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) received FDA 510(k) clearance on 2012-08-03, under 510(k) number K121192.

Who is the listed applicant for NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)?

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 NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)?

The FDA product code for NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK) is LZA.

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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)K100694COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THANK013317TEKMEDIC 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: LZA)

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.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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