FDA.reportPublic FDA data

Lanhine

Primary DI
06971513688181
Brand
Lanhine
Company
Zhejiang Lanhine Medical Products Ltd.
Model
15604F
Published
2023-04-26
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

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211827000Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)Zhejiang Lanhine Medical Products, Ltd.2021-09-23FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971513688198PrimaryGS10
06971513688204PrimaryGS10
06971513688181Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971513688198069715136881986971513688198
06971513688204069715136882046971513688204
06971513688181069715136881816971513688181

GMDN Terms#

Term, Definition table
TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; 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). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.9Inch
Width3.7Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543514472
Device count
50
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971513688204Lanhine15604F2023-05-16
06971513688198Lanhine15604F2023-04-26
16971513688164Lanhine15604F2023-02-14
16971513688171Lanhine15604F2023-02-14
06971513688150Lanhine15604F2023-02-11
06971513689515Lanhine15604F2023-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
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