FDA.report

BAYLAB USA

Primary DI
00850025515092
Company
Baylab USA, LLC
Model
092
Device description
BAYLAB 3-Ply Surgical Masks (BEACON I) are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
117701382
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00850025515092PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00850025515092PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FXXMask, Surgical2General, Plastic Surgery878.4040NEligible

Premarket Submissions

SubmissionSupplement
K212302000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K212302000BAYLAB 3-Ply Surgical Mask (BEACON I)Baylab USA, LLC2021-12-07FXX

GMDN Terms

TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

No records found.

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