Medical Protective Mask (model: 8862 +5 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223068

by Guangdong Golden Leaves Technology Development Co., Ltd.

Identifiers

510(k) Number: K223068 FDA 510(k)
FDA Product Code: FXX FDA 510(k)
Models / Variants: model: 8862 FDA 510(k)
8862A FDA 510(k)
8862B FDA 510(k)
8862C FDA 510(k)
8862D FDA 510(k)
8862E FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4040 FDA 510(k)
Regulation Number: 878.4040 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Medical Protective Mask (model: 8862 +5 more) by Guangdong Golden Leaves Technology Development Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 6…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K223068	Class II	Active

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Manufacturer

Manufacturer: Guangdong Golden Leaves Technology Development Co., Ltd.

Sources (1)

FDA 510(k) K223068 24 fields · synced Jun 18, 2026