FDA 510(k)

POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE

K-Number: K101102 · 2010-07-16

Decision Date2010-07-16

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Best Putra Gloves Sdn Bhd. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K101102. 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 POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE?

POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Best Putra Gloves Sdn Bhd. The 510(k) number is K101102.

When did POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE receive FDA 510(k) clearance?

POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE received FDA 510(k) clearance on 2010-07-16, under 510(k) number K101102.

Who is the listed applicant for POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE?

The FDA 510(k) record lists Best Putra Gloves Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE?

The FDA product code for POWDER-FREE, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE is KGO.

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Other records listing Best Putra Gloves Sdn Bhd as applicant

K101105POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 K101106POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 K101103POWDERED, NATURAL COLOR, LATEX SURGICAL GLOVE, STERILE MODEL: MSP1

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.