FDA 510(k)

NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE

K-Number: K042378 · 2004-09-20

ApplicantShijiazhuang Tillotson Rubber Products Co., Ltd.

Decision Date2004-09-20

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Shijiazhuang Tillotson Rubber Products Co., Ltd.. It received FDA 510(k) clearance on 2004-09-20 under 510(k) number K042378. 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 NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE?

NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2004-09-20. The listed applicant is Shijiazhuang Tillotson Rubber Products Co., Ltd.. The 510(k) number is K042378.

When did NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE receive FDA 510(k) clearance?

NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE received FDA 510(k) clearance on 2004-09-20, under 510(k) number K042378.

Who is the listed applicant for NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE?

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

What is the FDA product code for NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE?

The FDA product code for NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVE is LZA.

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Other records listing Shijiazhuang Tillotson Rubber Products Co., Ltd. as applicant

K043014POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)

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.