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FDA 510(k)

SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES

K-Number: K994081 · 2000-01-18

ApplicantSafeskin Corp.
Decision Date2000-01-18
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Safeskin Corp.. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K994081. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES?

SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Safeskin Corp.. The 510(k) number is K994081.

When did SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES receive FDA 510(k) clearance?

SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES received FDA 510(k) clearance on 2000-01-18, under 510(k) number K994081.

Who is the listed applicant for SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES?

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 TACTYLON PF POWDER-FREE SURGEON'S GLOVES?

The FDA product code for SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES is KGO.

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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 AGK992830SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVEK992210SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVESK992162SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIMK992062SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVESK991951SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)

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Related Devices (Code: KGO)

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.

K260558Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl CitrateHartalega NGC Sdn. Bhd.K253060Sterile Latex Powder Free Surgical GlovesProtect Gloves Company LimitedK250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbHK240790Polyisoprene Surgical glovesSuzhou Colour-Way New Material Co., Ltd.K232079Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and FentanylWrp Asia Pacific Sdn. Bhd.K232444Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy DrugsGrand Work Plastic Products 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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