Dental Hygiene Tray
FDA 510(k) K944139 · Sterile Concepts, Inc.
510(k) numberK944139
Submission
- Device name
- Dental Hygiene Tray
- Applicant
- Sterile Concepts, Inc.
Richmond, VA, US - Received
- August 24, 1994
- Decision date
- December 15, 1994
- 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 |
|---|---|---|
| K951231 | Orthopedic PacksGAN · Traditional | 12/01/1995SE |
| K951081 | OB/GYN PacksKNA · Traditional | 11/13/1995SE |
| K952539 | Radiology PacksLRO · Traditional | 07/14/1995SE |
| K951478 | General and Plastic Surgery PacksLRO · Traditional | 06/13/1995SE |
| K943047 | IV Start KitsKMK · Traditional | 09/14/1994SE |
| K943090 | Suture Removal TraysFRG · Traditional | 08/22/1994SEKD |
| K940864 | Dentist with Assistant PackEIA · Traditional | 08/02/1994SE |
| K943046 | Skin Staple Removal TraysMCZ · Traditional | 07/29/1994SESK |
| K920763 | Lacerattion TrayKDD · Traditional | 09/28/1992SESK |
Questions and answers
When was Dental Hygiene Tray cleared by the FDA?
Dental Hygiene Tray (K944139) received a 510(k) decision of Substantially Equivalent on December 15, 1994, 113 days after the submission was received.
What is the product code of K944139?
The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.