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FDA 510(k)

STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

K-Number: K011066 · 2001-09-11

ApplicantSmart Glove Corp. Sdn Bhd
Decision Date2001-09-11
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Smart Glove Corp. Sdn Bhd. It received FDA 510(k) clearance on 2001-09-11 under 510(k) number K011066. 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 STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)?

STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 2001-09-11. The listed applicant is Smart Glove Corp. Sdn Bhd. The 510(k) number is K011066.

When did STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) received FDA 510(k) clearance on 2001-09-11, under 510(k) number K011066.

Who is the listed applicant for STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)?

The FDA 510(k) record lists Smart Glove Corp. Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)?

The FDA product code for STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) is KGO.

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Other records listing Smart Glove Corp. 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.

K091147POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K082370POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K081466STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUEK071170POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGELK063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K061724POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND 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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