Audiotone Model A97
FDA 510(k) K920092 · Miracle-Ear, Inc.
510(k) numberK920092
Submission
- Device name
- Audiotone Model A97
- Applicant
- Miracle-Ear, Inc.
Golden Valley, MN, US - Received
- January 8, 1992
- Decision date
- January 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LYY – Latex Patient Examination Glove
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6250
- Specialty
- General Hospital
A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Other 510(k)s with product code LYY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein…LYY · Traditional | Comfort Rubber Gloves Industries Sdn. Bhd. | 04/29/2025SE |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White)LYY · Abbreviated | Sri Trang Gloves (Thailand) Public Company Limited | 09/09/2024SE |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein…LYY · Traditional | Kossan International Sdn Bhd | 06/13/2023SE |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)LYY · Traditional | Shandong Intco Medical Products Co, Ltd. | 02/22/2023SE |
| K222612 | Powder-Free Latex examination glovesLYY · Traditional | Guangdong Kingfa Sci. & Tech.Co., Ltd. | 11/25/2022SE |
| K221667 | Non Sterile Powder Free Latex Examination GloveLYY · Traditional | New Era Medicare Sdn. Bhd. | 10/28/2022SE |
| K222348 | JR MedicLYY · Abbreviated | Jr Engineering & Medical Technologies (M) Sdn.… | 10/27/2022SE |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)LYY · Traditional | Hebei Titans Hongsen Medical Technology Co., Ltd. | 10/26/2022SE |
| K222693 | Single-use medical latex examination gloves (LG100)LYY · Traditional | Fitone Latex Products Co., Ltd. Guangdong | 09/24/2022SE |
| K221648 | Iconic Latex GloveLYY · Traditional | Iconic Medicare Sdn Bhd | 08/25/2022SE |
More from Iconic Medicare Sdn Bhd
| 510(k) | Device | Decision |
|---|---|---|
| K972346 | Miracle-Ear Ite DigitalESD · Traditional | 07/23/1997SE |
| K972345 | Dahlberg/Miracle-EarESD · Traditional | 07/23/1997SE |
| K972344 | Miracle-Ear Digital BteESD · Traditional | 07/23/1997SE |
| K970262 | Multi-Channel Compression Bte (SD)ESD · Traditional | 03/31/1997SE |
| K964419 | Miracle - Ear (Ite/Itc/Cic)ESD · Traditional | 02/04/1997SE |
| K965063 | Audiotone (A-552)ESD · Traditional | 01/27/1997SE |
| K965057 | Audiotone (A554H)ESD · Traditional | 01/27/1997SE |
| K965049 | Dahlberg (A-554)ESD · Traditional | 01/27/1997SE |
| K964669 | Miracle-Ear or AudiotoneESD · Traditional | 12/26/1996SE |
| K964794 | Dahlberg K-Amp BteESD · Traditional | 12/23/1996SE |
Questions and answers
When was Audiotone Model A97 cleared by the FDA?
Audiotone Model A97 (K920092) received a 510(k) decision of Substantially Equivalent on January 28, 1992, 20 days after the submission was received.
What is the product code of K920092?
The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.