| Device Type ID | 2812 |
| Device Name | Mask, Surgical |
| Regulation Description | Surgical Apparel. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FXX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2812 |
| Device | Mask, Surgical |
| Product Code | FXX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Apparel. |
| CFR Regulation Number | 878.4040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
3M HEALTH CARE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BH MEDICAL PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDINAL HEALTH 200, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
HALYARD HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PASTURE PHARMA PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRESTIGE AMERITECH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROTECT U GUARD, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAN-M PACKAGE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SKYPRO MEDICAL SUPPLIES COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WESTTEC, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
YTS GLOBAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Delivered As Unsterile Product | 39 |
Adverse Event Without Identified Device Or Use Problem | 16 |
No Apparent Adverse Event | 3 |
Patient-Device Incompatibility | 3 |
Patient Device Interaction Problem | 2 |
Component Incompatible | 1 |
Device Emits Odor | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Packaging Problem | 1 |
Insufficient Information | 1 |
Human-Device Interface Problem | 1 |
Compatibility Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 71 |