Definition: A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious
| Device Type ID | 2822 |
| Device Name | Surgeon's Gloves |
| Regulation Description | Non-powdered Surgeon's Glove. |
| 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 | 878.4460 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KGO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2822 |
| Device | Surgeon's Gloves |
| Product Code | KGO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Non-powdered Surgeon's Glove. |
| CFR Regulation Number | 878.4460 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANHUI ANYU LATEX PRODUCTS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANSELL HEALTHCARE PRODUCTS LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ANSELL HEALTHCARE PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDINAL HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CARDINAL HEALTH 200, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CARDINAL HEALTH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
EMERSON & CO. S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARTALEGA SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LUCENXIA PRESCIENCE AG | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MOLNLYCKE HEALTH CARE US LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MOLNLYCKE HEALTH CARE US, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PT. MEDISAFE TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PURNA BINA SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SANREA HEALTHCARE PRODUCTS PVT LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEMPERIT INVESTMENTS ASIA PTE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHANGHAI MOTEX HEALTHCARE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TERANG NUSA SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WEAR SAFE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WEAR SAFE (MALAYSIA) SDN BHD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Cross Reactivity | 3 |
Material Split, Cut Or Torn | 2 |
Patient-Device Incompatibility | 2 |
Device Operates Differently Than Expected | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Ingredient Or Reagent Problem | 1 |
Device Or Device Fragments Location Unknown | 1 |
Insufficient Information | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Contract Systems, Inc. | II | Nov-14-2018 |
| 2 | Ansell Healthcare Products LLC | II | Dec-22-2016 |
| 3 | Cardinal Health 200, LLC | II | Dec-19-2018 |
| 4 | Medline Industries Inc | II | Nov-21-2017 |
| 5 | WRP Asia Pacific Sdn Bhd | II | May-30-2018 |