Identity
- Trade Name
- OCEAN PACIFIC INTUITION FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Lilac - X-Small FDA UDI
- Model / Reference
- OPXS-IN FDA UDI
- Description
- Ocean Pacific Intuition - Nitrile Medical Examination Gloves - Chemotherapy Tested - Textured Fingertips - Powder Free - Non-Sterile - Lilac - X-Small FDA UDI
Identifiers
- Catalog Number
- OPXS-IN FDA UDI
- Primary DI / UDI-DI
- 10686864042522 FDA UDI
- 510(k) Number
- K162095 FDA UDI
- FDA Product Code
- LZA FDA UDILZC 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
Yes
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
Ocean Pacific Intuition by AMD Medicom Inc — 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
- Cypress — MCKESSON MEDICAL-SURGICAL INC. · Class I
Cleared under the same submission
K162095 also covers:
- Medicom AssureTouch — AMD Medicom Inc
- Medicom AssureTouch — AMD Medicom Inc
- Medicom AssureTouch — AMD Medicom Inc
- Medicom AssureTouch — AMD Medicom Inc
- Medicom AssureTouch — AMD Medicom Inc
- Medicom AssureTouch — AMD Medicom Inc
- OCEAN PACIFIC INTUITION — AMD Medicom Inc
- OCEAN PACIFIC INTUITION — AMD Medicom Inc
- OCEAN PACIFIC INTUITION — AMD Medicom Inc
- OCEAN PACIFIC INTUITION — AMD Medicom Inc
- OCEAN PACIFIC INTUITION — AMD Medicom Inc
- Ocean Pacific — AMD Medicom Inc
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- AMD Medicom Inc
Sources (1)
- FDA UDI a9f3a22b-731c-4051-b2b8-29d420104e2f 38 fields · synced Jun 6, 2026