FDA 510(k)

POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)

K-Number: K972195 · 1997-07-29

ApplicantAbsolute Synthetic Technologies Malaysia Sdn. Bhd.

Decision Date1997-07-29

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) is the device name listed in this FDA 510(k) record. The listed applicant is Absolute Synthetic Technologies Malaysia Sdn. Bhd.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K972195. 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 POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)?

POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Absolute Synthetic Technologies Malaysia Sdn. Bhd.. The 510(k) number is K972195.

When did POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) receive FDA 510(k) clearance?

POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) received FDA 510(k) clearance on 1997-07-29, under 510(k) number K972195.

Who is the listed applicant for POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)?

The FDA 510(k) record lists Absolute Synthetic Technologies Malaysia Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)?

The FDA product code for POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED) is LZA.

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Other records listing Absolute Synthetic Technologies Malaysia Sdn. Bhd. as applicant

K972838POWDER-FREE NITRILE, POLY-COATED EXAMINATION GLOVE, PURPLE OR WHITE (NON-COLORED)K972177POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)

Related Devices (Code: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.