FDA 510(k)

SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)

K-Number: K980880 · 1998-05-20

Decision Date1998-05-20

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) is the device name listed in this FDA 510(k) record. The listed applicant is Ansell Perry. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K980880. 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 SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)?

SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Ansell Perry. The 510(k) number is K980880.

When did SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) receive FDA 510(k) clearance?

SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) received FDA 510(k) clearance on 1998-05-20, under 510(k) number K980880.

Who is the listed applicant for SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)?

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

What is the FDA product code for SENSI-DERM LATEX SURGICAL GLOVES (POWDERED)?

The FDA product code for SENSI-DERM LATEX SURGICAL GLOVES (POWDERED) is KGO.

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Other records listing Ansell Perry as applicant

K003895X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 K002192DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 K001239ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K000165NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM K000295ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K993857THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR

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Related Devices (Code: KGO)

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 Limited K250313Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric AcidHarps Europe Manufacturing GmbH K240790Polyisoprene 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.