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Sign in to claim this brandTOP QUALITY MANUFACTURING, INC.
US
Last updated May 24, 2026
What TOP QUALITY MANUFACTURING, INC. makes
The company produces dental instruments and materials, including single-use diamond and carbide burs for tooth preparation, endodontic files and rasps for root canal procedures, and endodontic paper points for medication application. It also manufactures single-use medical drapes for equipment protection, natural gutta-percha for root canal filling, and non-powdered, non-antimicrobial examination gloves made from nitrile and natural latex.
These products are regulated under the FDA’s classification system as either Class I or Class II devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Top Quality Manufacturing, Inc. produce?
Top Quality Manufacturing, Inc. specializes in dental instruments and materials, including single-use diamond and carbide dental burs for tooth preparation, rotary/reciprocating endodontic files and rasps for root canal procedures, and endodontic paper points for medication delivery. They also manufacture single-use medical drapes for equipment protection, natural gutta-percha for root canal filling, and non-powdered, non-antimicrobial examination gloves made from nitrile and natural latex.
Where is Top Quality Manufacturing, Inc. based?
The company is based in the United States, where it operates and produces its medical devices in compliance with applicable U.S. regulatory standards.
Which regulatory registries list Top Quality Manufacturing, Inc.’s devices?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices authorized for use in the U.S. This database helps ensure traceability and transparency in the supply chain.
How are Top Quality Manufacturing, Inc.’s devices classified under U.S. regulations?
The company’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards or special controls due to moderate risk. The classification depends on the specific device type and its intended use.
What distinguishes the gloves produced by Top Quality Manufacturing, Inc.?
The company manufactures two types of examination/treatment gloves: nitrile and natural latex, both of which are non-powdered and non-antimicrobial. These gloves are designed for medical examinations and procedures, offering protection without the risk of powder-related contamination or antimicrobial additives.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- topqualitygloves.com
- —
- —
- [email protected]
- Phone
- (800) 483-8559
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 113630649
Catalogue (899)
Page 7 of 18| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Top Quality Manufacturing | 18009156 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603291 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603199 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603385 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603196 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603371 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603118 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603459 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12619123 | FDA UDI | Class I | Active |
| SkinGard Nitrile Examination Gloves | P110 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12609252 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | BC2-2628 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 18015101 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603409 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603400 | FDA UDI | Class I | Active |
| 2ndSkin Nitrile Examination Gloves | BN010 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12609262 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12609161 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 18009144 | FDA UDI | Class I | Active |
| 2ndSkin Nitrile Examination Gloves | BN050 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603431 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603272 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 18015102 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603421 | FDA UDI | Class I | Active |
| Smile 300 Blue Nitrile Examination Gloves | B8300 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603259 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | BC2-2630 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603411 | FDA UDI | Class I | Active |
| Jeannie Nitrile Examination Gloves | P730 | FDA UDI | Class I | Active |
| BioGrip Nitrile Examination Gloves | W8840 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12609220 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | PA2-5525-F | FDA UDI | Class I | Active |
| Top Quality Manufacturing | BC2-2617 | FDA UDI | Class I | Active |
| Neoshield Polychloroprene Examination Gloves | PCP10 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12610123 | FDA UDI | Class I | Active |
| Neoshield Polychloroprene Examination Gloves | PC10 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603410 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 18009125 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12609226 | FDA UDI | Class I | Active |
| 2ndSkin Nitrile Examination Gloves | LG910 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603171 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603333 | FDA UDI | Class I | Active |
| Periwinkle Nitrile Examination Gloves | P1028 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12609172 | FDA UDI | Class I | Active |
| Vitaderm Latex Examination Gloves | N410 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 18009102 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | SE2-5560 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12603408 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | BC2-2634 | FDA UDI | Class I | Active |
| Top Quality Manufacturing | 12609170 | FDA UDI | Class I | Active |
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