Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Powdered Free Sterile Natural Rubber Latex Surgical Gloves

K-Number: K230832 · 2023-08-16

ApplicantThe Egyptian Company For Medical & Electronic Industries
Decision Date2023-08-16
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Powdered Free Sterile Natural Rubber Latex Surgical Gloves is the device name listed in this FDA 510(k) record. The listed applicant is The Egyptian Company For Medical & Electronic Industries. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K230832. 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 Free Sterile Natural Rubber Latex Surgical Gloves?

Powdered Free Sterile Natural Rubber Latex Surgical Gloves is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is The Egyptian Company For Medical & Electronic Industries. The 510(k) number is K230832.

When did Powdered Free Sterile Natural Rubber Latex Surgical Gloves receive FDA 510(k) clearance?

Powdered Free Sterile Natural Rubber Latex Surgical Gloves received FDA 510(k) clearance on 2023-08-16, under 510(k) number K230832.

Who is the listed applicant for Powdered Free Sterile Natural Rubber Latex Surgical Gloves?

The FDA 510(k) record lists The Egyptian Company For Medical & Electronic Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powdered Free Sterile Natural Rubber Latex Surgical Gloves?

The FDA product code for Powdered Free Sterile Natural Rubber Latex Surgical Gloves 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.

NCT06557499A 3-way Crossover Clinical Investigation to Assess the Performance of Two Different Sized Polyurethane Condoms Versus a Latex Condom in Healthy Monogamous Couples.COMPLETED

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.

↑