Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) And # 6512(65…

FDA 510(k)

Class I (US FDA 510(k))

510(k) K123126

Identifiers

510(k) Number: K123126 FDA 510(k)
FDA Product Code: KGO FDA 510(k)

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4460 FDA 510(k)
Regulation Number: 878.4460 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Motex Polyisoprene Powder-Free Surgical Gloves Model # 6412(6432) And # 6512(65… by Shanghai Motex Healthcare Co., Ltd. — Class I — FDA_510K — listed in FDA…

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	K123126	Class I	Active

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Manufacturer

Manufacturer: Shanghai Motex Healthcare Co., Ltd.

Sources (1)

FDA 510(k) K123126 24 fields · synced Jun 18, 2026