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Sign in to claim this brandSUMMIT GLOVE INC.
US
Last updated May 24, 2026
What SUMMIT GLOVE INC. makes
Summit Glove Inc. manufactures examination and treatment gloves, including nitrile and hevea-latex varieties, all of which are non-powdered and non-antimicrobial. Their product line includes single-use gloves designed for medical, dental, and laboratory procedures, with specific models like NitriTech, AdvanceFit, and Get-A-Grip. The company also produces AmbiCanner, a glove-related accessory for improved fit and dexterity.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The manufacturer operates from the United States, adhering to applicable regulatory requirements for medical gloves.
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 Summit Glove Inc. manufacture?
Summit Glove Inc. specializes in single-use examination and treatment gloves, including nitrile and hevea-latex varieties. All their gloves are non-powdered and non-antimicrobial, designed for medical, dental, and laboratory use. Examples include models like NitriTech, AdvanceFit, and Get-A-Grip, as well as accessories like AmbiCanner for enhanced fit and dexterity.
Where is Summit Glove Inc. based, and what does that mean for its regulatory compliance?
Summit Glove Inc. is based in the United States, meaning its devices must comply with FDA regulations. Since these gloves fall under Class I classification, they are subject to general controls but may still require registration, listing, and adherence to manufacturing practices outlined by the FDA.
Which regulatory databases list Summit Glove Inc.’s devices?
Summit Glove Inc.’s devices are listed in the FDA’s 510(k) database, which tracks premarket notifications for Class I devices, and the Unique Device Identifier (UDI) database, ensuring traceability and identification of medical devices in commerce.
How are Summit Glove Inc.’s gloves classified under FDA regulations?
Summit Glove Inc.’s gloves are classified as Class I devices under FDA regulations. This classification applies to low-risk medical devices like single-use gloves, which typically require general controls (such as proper labeling and manufacturing standards) rather than stringent premarket approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- summitglove.com
- —
- —
- [email protected]
- Phone
- 3308680066
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 054386458
Catalogue (235)
Page 4 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AmbiNitrile | 570-BL-11 | FDA UDI | Class I | Active |
| AmbiNitrile | 570-BL-7 | FDA UDI | Class I | Active |
| Intercept Free | 91140-EC | FDA UDI | Class I | Active |
| AdvanceFit | 650-BK-2XL | FDA UDI | Class I | Active |
| Get-A-Grip | 79750PF-BKGR | FDA UDI | Class I | Unknown |
| Get-A-Grip | OPI0814XXXL | FDA UDI | Class I | Active |
| ResQ-Grip | 79730PF-BKGR | FDA UDI | Class I | Unknown |
| 767PF Series | 76730PF-M | FDA UDI | Class I | Active |
| AmbiCanner | 470-10-BL | FDA UDI | Class I | Active |
| AmbiCanner | 470-8-BL | FDA UDI | Class I | Active |
| AdvanceFit | 650-LB-M | FDA UDI | Class I | Active |
| ResQ-Grip | 79760PF-BKGR | FDA UDI | Class I | Unknown |
| Intercept Free | 91160-EC | FDA UDI | Class I | Active |
| NitriTech Ultra | 61050PF-XL | FDA UDI | Class I | Active |
| Get-A-Grip | 79740PF-BKGR | FDA UDI | Class I | Active |
| Get-A-Grip | 79720PF-BKGR | FDA UDI | Class I | Unknown |
| Get-A-Grip | OPI0812XL | FDA UDI | Class I | Active |
| NitriTech Ultra | 61030PF-M | FDA UDI | Class I | Active |
| Get-A-Grip | 79720PF-BKGR | FDA UDI | Class I | Active |
| AdvanceFit | 650-LB-XL | FDA UDI | Class I | Active |
| NitriTech Ultra | 61020PF-S | FDA UDI | Class I | Active |
| NitriTech Ultra | 61030PF-M | FDA UDI | Class I | Active |
| Get-A-Grip | 79770PF-BKGR | FDA UDI | Class I | Active |
| Intercept Free | 91140-EC | FDA UDI | Class I | Active |
| 767PF Series | 76750PF-XL | FDA UDI | Class I | Active |
| Get-A-Grip | 79770PF-BKGR | FDA UDI | Class I | Active |
| AdvanceFit | 650-BK-XL | FDA UDI | Class I | Active |
| NitriTech Ultra | 61060PF-2XL | FDA UDI | Class I | Active |
| NitriTech Ultra | 61050PF-XL | FDA UDI | Class I | Active |
| Get-A-Grip | 79770PF-BKGR | FDA UDI | Class I | Active |
| Get-A-Grip | 79760PF-RBGR | FDA UDI | Class I | Active |
| NitriTech Ultra | 61020PF-S | FDA UDI | Class I | Active |
| Get-A-Grip | 79750PF-BKGR | FDA UDI | Class I | Active |
| 767PF Series | 76730PF-M | FDA UDI | Class I | Active |
| NitriTech Ultra | 61070PF-3XL | FDA UDI | Class I | Active |
| NitriTech SS | 75750PF-XL | FDA UDI | Class I | Active |
| AmbiNitrile | 570-GR-7 | FDA UDI | Class I | Active |
| AdvanceFit | 650-BK-XL | FDA UDI | Class I | Active |
| Get-A-Grip | OPI0809S | FDA UDI | Class I | Active |
| NitriTech | 75750PF-XL | FDA UDI | Class I | Active |
| AdvanceFit | 650-LB-2XL | FDA UDI | Class I | Active |
| 767PF Series | 76720PF-S | FDA UDI | Class I | Active |
| AdvanceFit | 650-OR-XL | FDA UDI | Class I | Active |
| Get-A-Grip | 79720PF-RBGR | FDA UDI | Class I | Active |
| AmbiNitrile | 570-BL-11 | FDA UDI | Class I | Active |
| NitriTech Ultra | 61030PF-M | FDA UDI | Class I | Active |
| AmbiNitrile | 570-BL-10 | FDA UDI | Class I | Active |
| Milker's Helpers | 71960PF | FDA UDI | Class I | Active |
| Get-A-Grip | 79720PF-BKGR | FDA UDI | Class I | Active |
| AdvanceFit | 650-OR-L | FDA UDI | Class I | Active |
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