FDA 510(k)

SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES

K-Number: K101943 · 2010-11-08

ApplicantTangshan Jiteng Plastic Products Co., Ltd.

Decision Date2010-11-08

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Tangshan Jiteng Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2010-11-08 under 510(k) number K101943. 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 SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES?

SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2010-11-08. The listed applicant is Tangshan Jiteng Plastic Products Co., Ltd.. The 510(k) number is K101943.

When did SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 2010-11-08, under 510(k) number K101943.

Who is the listed applicant for SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES?

The FDA 510(k) record lists Tangshan Jiteng Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES?

The FDA product code for SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Tangshan Jiteng Plastic Products Co., Ltd. as applicant

K100074POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)K100075POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)K090537POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (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.