FDA.reportPublic FDA data

Top Quality Manufacturing

Primary DI
TQ26126151040
Brand
Top Quality Manufacturing
Company
TOP QUALITY MANUFACTURING, INC.
Model
12615104
Device description
TQMPL Shoe Cover - Blue Regular 15in
Published
2024-12-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWPSHOE AND SHOE COVER, CONDUCTIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWPShoe And Shoe Cover, ConductiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
TQ26126151041PrimaryHIBCC0
TQ26126151040Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)483-8559regulatory@topqualitygloves.com

Regulatory Flags#

DUNS number
113630649
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
TQ26126092411Top Quality Manufacturing126092412024-10-30
TQ26126092431Top Quality Manufacturing126092432024-10-28
TQ26126092441Top Quality Manufacturing126092442024-10-28
TQ26126092501Top Quality Manufacturing126092502024-10-28
TQ26126092521Top Quality Manufacturing126092522024-10-28
TQ26126092531Top Quality Manufacturing126092532024-10-28
TQ26126092551Top Quality Manufacturing126092552024-10-28
TQ26126092561Top Quality Manufacturing126092562024-10-28
TQ26126092571Top Quality Manufacturing126092572024-10-28
TQ26126092581Top Quality Manufacturing126092582024-10-28
TQ26126092621Top Quality Manufacturing126092622024-10-28
TQ26126092641Top Quality Manufacturing126092642024-10-28
TQ26126092661Top Quality Manufacturing126092662024-10-28
TQ26126092681Top Quality Manufacturing126092682024-10-28
TQ26126092691Top Quality Manufacturing126092692024-10-28
TQ26126092701Top Quality Manufacturing126092702024-10-28
TQ26126092721Top Quality Manufacturing126092722024-10-28
TQ26126092731Top Quality Manufacturing126092732024-10-28
TQ26126092791Top Quality Manufacturing126092792024-10-28
TQ26126092831Top Quality Manufacturing126092832024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330706596ProCureTwin Med, LLCBWP2026-05-05
00688162000665ProtexerICP MEDICAL, LLCBWP2026-04-27
00688162000672ProtexerICP MEDICAL, LLCBWP2026-04-27
10817583020342Critical CoverAlpha Pro Tech, Inc.BWP2026-04-16
00688162000023ProtexerICP MEDICAL, LLCBWP2025-08-19
00813360021789ProtexerICP MEDICAL, LLCBWP2025-08-19
00813360021796ProtexerICP MEDICAL, LLCBWP2025-08-19
10688162000020ProtexerICP MEDICAL, LLCBWP2025-08-19
10813360021786ProtexerICP MEDICAL, LLCBWP2025-08-19
10813360021793ProtexerICP MEDICAL, LLCBWP2025-08-19
00810184641032GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641049GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641056GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641063GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641070GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641087GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642589GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642596GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641407GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641414GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641421GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641438GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641445GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641452GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642763GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642770GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00850061859037GCB Medical Supply NovaplusGCB MEDICAL LLCBWP2025-07-23
00850061859136GCB Medical Supply NovaplusGCB MEDICAL LLCBWP2025-07-23
TQ26126151041Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.BWP2024-12-09
06950471300076OPERATING-ROOM SHOE COVERHangzhou A-Tek Medical & Textiles Co., Ltd.BWP2023-07-18