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FDA 510(k)

INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE

K-Number: K993325 · 1999-11-05

ApplicantInnovative Gloves Co;, Ltd.
Decision Date1999-11-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Gloves Co;, Ltd.. It received FDA 510(k) clearance on 1999-11-05 under 510(k) number K993325. 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 INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE?

INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE is a medical device that received FDA 510(k) clearance on 1999-11-05. The listed applicant is Innovative Gloves Co;, Ltd.. The 510(k) number is K993325.

When did INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE receive FDA 510(k) clearance?

INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE received FDA 510(k) clearance on 1999-11-05, under 510(k) number K993325.

Who is the listed applicant for INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE?

The FDA 510(k) record lists Innovative Gloves Co;, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE?

The FDA product code for INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE is LZA.

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Other records listing Innovative Gloves Co;, Ltd. 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.

K111158LATEX EXAMINATION GLOVES POWDER-FREE (BLACK COLOR) WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)K103670NITRILE EXAMINATION GLOVES POLYMER COATED (WHITE, BLUE, AND BLACK COLOR)K083908BLACK NITRILE EXAMINATION GLOVESK021668NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)K013333LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL CLAIMK993567INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]

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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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