SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD · 89-08 · CHINA

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
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
Address: 6728 YONGQING ST , LINQU, Shandong CHINA verified
Date published: 01/09/2024 verified
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 each item verified
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 each item verified

Sourceaccessdata.fda.gov

Verified2026-09-16

Review by2026-11-15

DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.

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SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD · 89-08 · CHINA

What the source says

Source

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