← Back to catalogue

Surgiplus

FDA UDI

Class II (US FDA UDI)

by Kenpax International Limited

Identity

Trade Name
SURGIPLUS FDA UDI
Generic Name
Surgical/medical face mask, single-use FDA UDI
Device Name
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. the mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile, meet ASTM F2100 LEVEL 3. The Surgical Mask is single use, three-layer, flat –folded masks with ties and nose wire. This Mask is manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mask close to the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in green and Blue. The surgical mask is sold non-sterile and are intended to be single use, disposable device. FDA UDI
Model / Reference
1 FDA UDI
Description
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. the mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile, meet ASTM F2100 LEVEL 3. The Surgical Mask is single use, three-layer, flat –folded masks with ties and nose wire. This Mask is manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mask close to the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in green and Blue. The surgical mask is sold non-sterile and are intended to be single use, disposable device. FDA UDI

Identifiers

Catalog Number
68-8518-B FDA UDI
Primary DI / UDI-DI
74895237109115 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical/medical face mask, single-use

Surgiplus by Kenpax International Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kenpax International Limited

Sources (1)

  • FDA UDI 265cb741-b879-461a-ae80-5c75120d540a 34 fields · synced Jun 8, 2026