21 CFR 880.6250 — Patient Examination Glove
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6250
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FMC | Patient Examination Glove | 1 | 34 | 3rd Party |
| LYY | Latex Patient Examination Glove | 1 | 1954 | 3rd Party |
| LYZ | Vinyl Patient Examination Glove | 1 | 799 | 3rd Party |
| LZA | Polymer Patient Examination Glove | 1 | 1168 | 3rd Party |
| LZB | Finger Cot | 1 | 5 | |
| LZC | Medical Glove, Specialty | 1 | 79 | 3rd Party |
| OIG | Powder-Free Guayle Rubber Examination Glove | 1 | 1 | 3rd Party |
| OPC | Powder-Free Polychloroprene Patient Examination Glove | 1 | 1 | 3rd Party |
| OPH | Radiation Attenuating Medical Glove | 1 | 0 | 3rd Party |
| OPJ | Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | 1 | 0 | 3rd Party |
| PWP | Blood Borne Pathogen Response Kit | 1 | 0 | |
| PWS | Chemotherapy Administration Kit | 1 | 0 | |
| PWT | Chemotherapy Spill Clean-Up Kit | 1 | 0 | |
| PWV | Delivery Room Apparel Kit | 1 | 0 | |
| PXC | Personal Protection Kit | 1 | 0 | |
| PXD | Prep Kit | 1 | 0 | |
| QDO | Fentanyl And Other Opioid Protection Glove | 1 | 0 |
