Decision Date2002-12-30
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. It received FDA 510(k) clearance on 2002-12-30 under 510(k) number K024130. 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 POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE?
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE is a medical device that received FDA 510(k) clearance on 2002-12-30. The listed applicant is Wrp Asia Pacific Sdn. Bhd.. The 510(k) number is K024130.
When did POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE receive FDA 510(k) clearance?
POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE received FDA 510(k) clearance on 2002-12-30, under 510(k) number K024130.
Who is the listed applicant for POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE?
The FDA 510(k) record lists Wrp Asia Pacific Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE?
The FDA product code for POWDER FREE POLYMER COATED GREEN NEOPRENE SURGICAL GLOVES, STERILE is KGO.
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Other records listing Wrp Asia Pacific Sdn. Bhd. as applicant
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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.