SUPERFIT
GUDID 10814639023388
SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.5.
APPLIED DENTAL, INC.
Hevea-latex surgical glove, non-powdered, antimicrobial| Primary Device ID | 10814639023388 |
| NIH Device Record Key | 5a270588-7425-45d1-85a4-ced3ffa69814 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUPERFIT |
| Version Model Number | A520-LTX65 |
| Company DUNS | 017524666 |
| Company Name | APPLIED DENTAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com | |
| Phone | 1-888-841-8481 |
| info.usa@AD-Surgical.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814639023381 [Primary] |
| GS1 | 10814639023388 [Package] Contains: 00814639023381 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 20814639023385 [Package] Package: Carton [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063757
FDA Product Code
| KGO | Surgeon'S Gloves |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
On-Brand Devices [SUPERFIT ]
| 10814639024972 | SUPERFIT Disposable Procedural Face masks, Ear Loops. Level II |
| 10814639024965 | SUPERFIT Surgical Disposable Isolation Gown. Level II. |
| 10814639023418 | SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 8.0. |
| 10814639023401 | SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 7.5. |
| 10814639023395 | SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 7.0. |
| 10814639023388 | SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.5. |
| 10814639023371 | SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.0. |
| 10814639023265 | SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 8.5. Sterile. |
| 10814639023241 | SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 8.0. Sterile. |
| 10814639023234 | SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 7.5. Sterile. |
| 10814639023210 | SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 7.0. Sterile. |
| 10814639023203 | SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 6.5. Sterile. |
| 10814639023180 | SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 6.0. Sterile. |
Trademark Results [SUPERFIT]
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