Identity
- Trade Name
- Scott's Select Nitrile Gloves FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Powder Free Exam Gloves, size Extra Small. Features & Benefits: Super soft and stretchy formulation, provides natural feel, superior tactile sensitivity, textured fingertip provides exceptional grip, 300 per box, 10 boxes per case. For more information visit https://www.scottsdental.com/scotts-select-nitrile-gloves.html?queryID=617090b7aff0499e933ca4b49c1fa586&objectID=32034&indexName=magento2_production_default_products FDA UDI
- Model / Reference
- 350-5499 FDA UDI
- Description
- Nitrile Powder Free Exam Gloves, size Extra Small. Features & Benefits: Super soft and stretchy formulation, provides natural feel, superior tactile sensitivity, textured fingertip provides exceptional grip, 300 per box, 10 boxes per case. For more information visit https://www.scottsdental.com/scotts-select-nitrile-gloves.html?queryID=617090b7aff0499e933ca4b49c1fa586&objectID=32034&indexName=magento2_production_default_products FDA UDI
Identifiers
- Catalog Number
- 350-5499 FDA UDI
- Primary DI / UDI-DI
- D77835054991 FDA UDI
- 510(k) Number
- K052666 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Scott's Select Nitrile Gloves by Scott's Dental Supply L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
- VitalGard® Nitrile — Dash Medical Gloves, Inc. · Class I
- Hongray — Grand Work Plastic Products Co., Ltd. · Class I
- Get-A-Grip — SUMMIT GLOVE INC. · Class I
- MARK3 — CARGUS INTERNATIONAL, INC · Class I
- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
- FINISHMASTER — Bunzl USA Holdings LLC · Class I
- Medicom AssureTouch — AMD Medicom Inc · Class I
Cleared under the same submission
K052666 also covers:
- Beesure — ASCEND EAGLE INCORPORATED
- Beesure — ASCEND EAGLE INCORPORATED
- Beesure — ASCEND EAGLE INCORPORATED
- Cranberry — ASCEND EAGLE INCORPORATED
- Cranberry — ASCEND EAGLE INCORPORATED
- Cranberry — ASCEND EAGLE INCORPORATED
- Cranberry — ASCEND EAGLE INCORPORATED
- Cranberry — ASCEND EAGLE INCORPORATED
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC
- Scott's Select Latex Gloves — SCOTT'S DENTAL SUPPLY L.L.C.
- Scott's Select Latex Gloves — SCOTT'S DENTAL SUPPLY L.L.C.
- Scott's Select Latex Gloves — SCOTT'S DENTAL SUPPLY L.L.C.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Scott's Dental Supply L.l.c.
Sources (1)
- FDA UDI e0458459-dfe1-4555-b8c9-e09cc4dc5dc1 36 fields · synced May 30, 2026