# SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD · 89-08 · CHINA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CHINA; product is Medline FitGuard Select Powder Free Nitrile Exam Gloves | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Medline FitGuard Select Powder Free Nitrile Exam Gloves | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Powder-Free Nitrile Patient Examination Gloves Blue Color | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Medline FitGuard Select Powder Free Nitrile Exam Gloves | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Medline FitGuard Select Powder Free Nitrile Exam Gloves; product code is 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty | 80 L - - ZC Glove, Patient Examination, Specialty; date published is 01/09/2024; address is 6728 YONGQING ST , LINQU, Shandong CHINA, verified against its source on 2026-09-16.

- **Firm:** SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** 6728 YONGQING ST , LINQU, Shandong CHINA _(verified: appears in the quote below)_
- **Date published:** 01/09/2024 _(verified: appears in the quote below)_
- **Product code:** 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty | 80 L - - ZC Glove, Patient Examination, Specialty _(verified: each item appears in the quote below)_
- **Product:** Medline FitGuard Select Powder Free Nitrile Exam Gloves | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Medline FitGuard Select Powder Free Nitrile Exam Gloves | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Powder-Free Nitrile Patient Examination Gloves Blue Color | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Medline FitGuard Select Powder Free Nitrile Exam Gloves | Medline FitGuard Prime Powder-Free Nitrile Exam Gloves | Medline FitGuard Select Powder Free Nitrile Exam Gloves _(verified: each item appears in the quote below)_

## What the source says

> SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD Date Published : 01/09/2024 6728 YONGQING ST , LINQU, Shandong CHINA 80 L - - YY Glove, Patient Examination, Latex Date Published: 01/09/2024 Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves 80 L - - YY Glove, Patient Examination, Latex Date Published: 01/29/2024 Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves 80 L - - YZ Glove, Patient Examination, Vinyl Date Published: 01/09/2024 Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves 80 L - - YZ Glove, Patient Examination, Vinyl Date Published: 01/29/2024 Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves 80 L - - ZA Glove, Patient Examination, Poly Date Published: 02/23/2024 Desc: Powder-Free Nitrile Patient Examination Gloves Blue Color Notes: 80 L - - ZA Glove, Patient Examination, Poly Date Published: 01/29/2024 Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves 80 L - - ZA Glove, Patient Examination, Poly Date Published: 01/09/2024 Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 01/29/2024 Desc: Medline FitGuard Prime Powder-Free Nitrile Exam Gloves 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 01/09/2024 Desc: Medline FitGuard Select Powder Free Nitrile Exam Gloves

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).