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FDA 510(k)

POWDERED LATEX SURGICAL GLOVE

K-Number: K062797 · 2007-04-11

ApplicantBeijing Reagent Latex Products Co., Ltd.
Decision Date2007-04-11
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX SURGICAL GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Reagent Latex Products Co., Ltd.. It received FDA 510(k) clearance on 2007-04-11 under 510(k) number K062797. 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 POWDERED LATEX SURGICAL GLOVE?

POWDERED LATEX SURGICAL GLOVE is a medical device that received FDA 510(k) clearance on 2007-04-11. The listed applicant is Beijing Reagent Latex Products Co., Ltd.. The 510(k) number is K062797.

When did POWDERED LATEX SURGICAL GLOVE receive FDA 510(k) clearance?

POWDERED LATEX SURGICAL GLOVE received FDA 510(k) clearance on 2007-04-11, under 510(k) number K062797.

Who is the listed applicant for POWDERED LATEX SURGICAL GLOVE?

The FDA 510(k) record lists Beijing Reagent Latex Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED LATEX SURGICAL GLOVE?

The FDA product code for POWDERED LATEX SURGICAL GLOVE is KGO.

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Other records listing Beijing Reagent Latex Products Co., Ltd. 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.

K211515Nitrile Examination GlovesK012104SNOW LOTUS POWDER-FREE LATEX SURGEON'S GLOVESK010947SNOW LOTUS POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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