Decision Date1999-10-21
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SURGEON POWDER-FREE GLOVES, LATEX, STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Wear Safe Malaysia Sdn. Bhd.. It received FDA 510(k) clearance on 1999-10-21 under 510(k) number K992679. 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 SURGEON POWDER-FREE GLOVES, LATEX, STERILE?
SURGEON POWDER-FREE GLOVES, LATEX, STERILE is a medical device that received FDA 510(k) clearance on 1999-10-21. The listed applicant is Wear Safe Malaysia Sdn. Bhd.. The 510(k) number is K992679.
When did SURGEON POWDER-FREE GLOVES, LATEX, STERILE receive FDA 510(k) clearance?
SURGEON POWDER-FREE GLOVES, LATEX, STERILE received FDA 510(k) clearance on 1999-10-21, under 510(k) number K992679.
Who is the listed applicant for SURGEON POWDER-FREE GLOVES, LATEX, STERILE?
The FDA 510(k) record lists Wear Safe Malaysia Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SURGEON POWDER-FREE GLOVES, LATEX, STERILE?
The FDA product code for SURGEON POWDER-FREE GLOVES, LATEX, STERILE is KGO.
Related Clinical Trials
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Other records listing Wear Safe Malaysia Sdn. Bhd. 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.
K172420Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling ClaimK101799POWDER FREE LATEX EXAMINATION GLOVES BLUE (COLORED), NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50UG PER DM2 OF GLOVEK093500POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILEK092492POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OK090066POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 OF GLOVEK090327POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE View all 14 devices →
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.