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FDA 510(k)

Sterile Nitrile Surgical Gloves Powder Free

K-Number: K222350 · 2023-04-13

ApplicantJr Engineering & Medical Technologies (M) Sdn. Bhd.
Decision Date2023-04-13
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Nitrile Surgical Gloves Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K222350. 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 Nitrile Surgical Gloves Powder Free?

Sterile Nitrile Surgical Gloves Powder Free is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Jr Engineering & Medical Technologies (M) Sdn. Bhd.. The 510(k) number is K222350.

When did Sterile Nitrile Surgical Gloves Powder Free receive FDA 510(k) clearance?

Sterile Nitrile Surgical Gloves Powder Free received FDA 510(k) clearance on 2023-04-13, under 510(k) number K222350.

Who is the listed applicant for Sterile Nitrile Surgical Gloves Powder Free?

The FDA 510(k) record lists Jr Engineering & Medical Technologies (M) Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Nitrile Surgical Gloves Powder Free?

The FDA product code for Sterile Nitrile Surgical Gloves Powder Free is KGO.

Other records listing Jr Engineering & Medical Technologies (M) 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.

K221626Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl CitrateK222348JR MEDICK221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackK222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)K221157JR MedicK212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs

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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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