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FDA 510(k)

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein

K-Number: K190632 · 2019-10-24

ApplicantLenora Glove Pvt , Ltd.
Decision Date2019-10-24
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein is the device name listed in this FDA 510(k) record. The listed applicant is Lenora Glove Pvt , Ltd.. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190632. 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 Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein?

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Lenora Glove Pvt , Ltd.. The 510(k) number is K190632.

When did Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein receive FDA 510(k) clearance?

Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190632.

Who is the listed applicant for Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein?

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

What is the FDA product code for Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein?

The FDA product code for Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein is KGO.

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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

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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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