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)

Sterile Latex Surgical Glove, Powder Free

K-Number: K190241 · 2019-12-30

Decision Date2019-12-30
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterile Latex Surgical Glove, Powder Free is the device name listed in this FDA 510(k) record. The listed applicant is Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2019-12-30 under 510(k) number K190241. 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 Latex Surgical Glove, Powder Free?

Sterile Latex Surgical Glove, Powder Free is a medical device that received FDA 510(k) clearance on 2019-12-30. The listed applicant is Careglove Global Sdn. Bhd.. The 510(k) number is K190241.

When did Sterile Latex Surgical Glove, Powder Free receive FDA 510(k) clearance?

Sterile Latex Surgical Glove, Powder Free received FDA 510(k) clearance on 2019-12-30, under 510(k) number K190241.

Who is the listed applicant for Sterile Latex Surgical Glove, Powder Free?

The FDA 510(k) record lists Careglove Global Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Latex Surgical Glove, Powder Free?

The FDA product code for Sterile Latex Surgical Glove, Powder Free is KGO.

Other records listing Careglove Global 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.

View all 8 devices →

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.

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.