Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K203483

Identifiers

510(k) Number: K203483 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)

Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves by Guilin Hbm Health Protections, Inc. — Class I — MDR, FDA_510K — listed in FDA 510(k)…

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Active
FDA 510(k)	United States	FDA_510K	K203483	Class I	Active

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Manufacturer

Manufacturer: Guilin Hbm Health Protections, Inc.

Sources (2)

FDA 510(k) K203483 24 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced Jun 18, 2026