Boundary Reinforced Single-Use Gowns
FDA 510(k) K834339 · Procter & Gamble Mfg. Co.
510(k) numberK834339
Submission
- Device name
- Boundary Reinforced Single-Use Gowns
- Applicant
- Procter & Gamble Mfg. Co.
Mchenry, IL, US - Received
- December 12, 1983
- Decision date
- March 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Procter & Gamble Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K873457 | Scented or Scented Deodorized Menstrual PadsHIL · Traditional | 01/19/1988SE |
| K873036 | Attends Incontinent BriefEYQ · Traditional | 01/19/1988SE |
| K864673 | Unscented Menstrual PadHHL · Traditional | 01/21/1987SE |
| K861863 | Modified Protective GarmentEYQ · Traditional | 08/11/1986SE |
| K862348 | Single-Use Patient UnderpadKME · Traditional | 07/02/1986SE |
| K860598 | Modified Protective Garment for IncontinentsEYQ · Traditional | 03/05/1986SE |
| K853880 | Attends Dispos. UnderpadKME · Traditional | 10/16/1985SE |
| K853000 | Scented Always PantilinersHHL · Traditional | 09/06/1985SE |
| K852985 | Unscented Always PantilinersHHD · Traditional | 08/29/1985SE |
| K850956 | Always Maxipads - ScentedHHL · Traditional | 05/14/1985SE |
Questions and answers
When was Boundary Reinforced Single-Use Gowns cleared by the FDA?
Boundary Reinforced Single-Use Gowns (K834339) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 84 days after the submission was received.