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FDA 510(k)

SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM

K-Number: K992162 · 1999-08-30

ApplicantSafeskin Corp.
Decision Date1999-08-30
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM is the device name listed in this FDA 510(k) record. The listed applicant is Safeskin Corp.. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K992162. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM?

SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is Safeskin Corp.. The 510(k) number is K992162.

When did SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM receive FDA 510(k) clearance?

SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM received FDA 510(k) clearance on 1999-08-30, under 510(k) number K992162.

Who is the listed applicant for SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM?

The FDA 510(k) record lists Safeskin Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM?

The FDA product code for SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM is LZC.

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Other records listing Safeskin Corp. 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.

K993117SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AGK994081SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVESK992830SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVEK992210SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVESK992062SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVESK991951SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)

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Related Devices (Code: LZC)

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.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

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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