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Powder Free Nitrile Examination Gloves, Colored (Green +4 more)

FDA 510(k)

Class I (US FDA 510(k))

510(k) K220859

by Careglove Global Sdn. Bhd.

Identifiers

510(k) Number
K220859 FDA 510(k)
FDA Product Code
LZA FDA 510(k)
Models / Variants
Green FDA 510(k)
Orange FDA 510(k)
Purple FDA 510(k)
White FDA 510(k)
& Black FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 880.6250 FDA 510(k)
Regulation Number
880.6250 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Powder Free Nitrile Examination Gloves, Colored (Green +4 more) by Careglove Global Sdn. Bhd. — Class I — FDA_510K — listed in FDA 510(k) — 5 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Careglove Global Sdn. Bhd.

Sources (1)

  • FDA 510(k) K220859 24 fields · synced Jun 18, 2026