Description
This standard specifies requirements for packaged sterile rubber gloves intended for use in surgical procedures to protect the patient and the user from cross-contamination. It is applicable to single-use gloves that are worn once and then discarded.
TABLE OF CONTENTS
| Contents | Page |
| 1 Scope | 1 |
| 2 Normative references | 1 |
| 3 Classification | 1 |
| 3.1 General | 1 |
| 3.2 Type | 1 |
| 3.3 Design | 1 |
| 3.4 Finish | 2 |
| 4 Materials | 2 |
| 5 Sampling and selection of test piece | 2 |
| 5.1 Sampling | 2 |
| 5.2 Selection of test pieces | 3 |
| 6 Requirements | 3 |
| 6.1 Dimensions | 3 |
| 6.2 Watertightness | 5 |
| 6.3 Tensile properties | 5 |
| 6.4 Sterility | 6 |
| 7 Packaging | 6 |
| 8 Marking | 6 |
| 8.1 General | 6 |
| 8.2 Inner package | 6 |
| 8.3 Unit package | 7 |
| 8.4 Multi-unit package | 7 |
| Annex A (normative) Tests for watertightness | 8 |