FDA 510(k)

LATEX SURGICAL GLOVES, PRE-POWDERED

K-Number: K993450 · 1999-12-29

ApplicantFitco Dipped Products Pvt., Ltd.

Decision Date1999-12-29

Product CodeKGO

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LATEX SURGICAL GLOVES, PRE-POWDERED is the device name listed in this FDA 510(k) record. The listed applicant is Fitco Dipped Products Pvt., Ltd.. It received FDA 510(k) clearance on 1999-12-29 under 510(k) number K993450. 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 LATEX SURGICAL GLOVES, PRE-POWDERED?

LATEX SURGICAL GLOVES, PRE-POWDERED is a medical device that received FDA 510(k) clearance on 1999-12-29. The listed applicant is Fitco Dipped Products Pvt., Ltd.. The 510(k) number is K993450.

When did LATEX SURGICAL GLOVES, PRE-POWDERED receive FDA 510(k) clearance?

LATEX SURGICAL GLOVES, PRE-POWDERED received FDA 510(k) clearance on 1999-12-29, under 510(k) number K993450.

Who is the listed applicant for LATEX SURGICAL GLOVES, PRE-POWDERED?

The FDA 510(k) record lists Fitco Dipped Products Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX SURGICAL GLOVES, PRE-POWDERED?

The FDA product code for LATEX SURGICAL GLOVES, PRE-POWDERED is KGO.

Related Clinical Trials

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.

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Other records listing Fitco Dipped Products Pvt., Ltd. as applicant

K001715POWDERED PATIENT EXAMINATION GLOVES, LATEX K001232NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM 50 MICROGRAMS OR LESS K000896POWDERFREE LATEX SURGEON'S GLOVES WITH PROTIEN LABELING CLAIM (50 MOCROGRAMS OR LESS K000891STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES K001216POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)

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.