Guilin HBM Health Protections, Inc.

Manufacturer and brand owner in Guilin, Guangxi, China. 2 device types, 1 product catalogued, 2 clearances.

Registry build 21.09.26

Guilin HBM Health Protections, Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Surgeon’S Gloves, Radiographic Protective Glove. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2021.

2device types registered with the FDA
1product
2510(k) clearances

Registration

FDA registration record for Guilin HBM Health Protections, Inc.
Registered name GUILIN HBM HEALTH PROTECTIONS, INC.
Status Registered
Registration expires 2026
Registration number 3018299689
FEI number 3018299689
DUNS 553958608
Establishment type Manufacturer

Location

Address of Guilin HBM Health Protections, Inc.
City Guilin
Province Guangxi
Address No.1-2, Shuijing East Road, Economic and Technological Development Area
Postal code 541805
Country China

What It Makes

Device types Guilin HBM Health Protections, Inc. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Radiographic Protective Glove Class 1 Radiation Protection Surgical Gloves 2023 30
Surgeon’S Gloves Class 1 Medizero Underglove Surgical Gloves, Medizero Polyisoprene Surgical Glove, Medizero Latex Surgical Glove, Medizero Latex Surgical Gloves 2021 10

Own-Brand Listings

Devices catalogued by Guilin HBM Health Protections, Inc.
Product Code Catalogue numbers
Dexters KGO 8

Clearances

2 clearances name Guilin HBM Health Protections, Inc. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Guilin HBM Health Protections, Inc. or its listings
Clearance Decision date Product code Route Held by
K221748 2022-09-13 KGO Traditional This company
K203483 2021-02-01 KGO Traditional This company
K050071 2005-05-11 KGO Traditional H.B.M. USA Co., Inc.

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

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2,581device types they are registered for
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