# Glovesworld Ind Head Office (frmrly- Perusahaan Intan Emas) · 80-04 · MALAYSIA — FDA import alert red lists: firms subject to detention without physical examination

For Glovesworld Ind Head Office (frmrly- Perusahaan Intan Emas) · 80-04 · MALAYSIA, import alert is 80-04; import alert name is "Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves"; country is MALAYSIA; product code is 80 F - - MC Glove, Patient Examination | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty; date published is 09/16/2009; address is 6th Fl, Wisma Chinese Chamber , 258 Jalan Ampang , Kuala Lumpur, WP Kuala Lumpur MALAYSIA, verified against its source on 2026-09-16.

- **Firm:** Glovesworld Ind Head Office (frmrly- Perusahaan Intan Emas) _(verified: appears in the quote below)_
- **Import alert:** 80-04
- **Import alert name:** "Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves"
- **Country:** MALAYSIA _(verified: appears in the quote below)_
- **Address:** 6th Fl, Wisma Chinese Chamber , 258 Jalan Ampang , Kuala Lumpur, WP Kuala Lumpur MALAYSIA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 80 F - - MC Glove, Patient Examination | 80 L - - YY Glove, Patient Examination, Latex | 80 L - - YZ Glove, Patient Examination, Vinyl | 80 L - - ZA Glove, Patient Examination, Poly | 80 L - - ZC Glove, Patient Examination, Specialty _(verified: each item appears in the quote below)_
- **Product:** A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. | A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. _(verified: each item appears in the quote below)_
- **FDA notes:** *** Level 3 (8/1/2000)Note | *** Level 3 (8/1/2000)Note | *** Level 3 (8/1/2000) Note | *** Level 3 (8/1/2000)Note | *** Level 3 (8/1/2000)Note _(verified: each item appears in the quote below)_

## What the source says

> Glovesworld Ind Head Office (frmrly- Perusahaan Intan Emas) Date Published : 09/16/2009 6th Fl, Wisma Chinese Chamber , 258 Jalan Ampang , Kuala Lumpur, WP Kuala Lumpur MALAYSIA 80 F - - MC Glove, Patient Examination Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (8/1/2000)Note 80 L - - YY Glove, Patient Examination, Latex Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (8/1/2000)Note 80 L - - YZ Glove, Patient Examination, Vinyl Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (8/1/2000) Note 80 L - - ZA Glove, Patient Examination, Poly Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (8/1/2000)Note 80 L - - ZC Glove, Patient Examination, Specialty Date Published: 09/16/2009 Desc: A Warning Letter has been issued to this firm citing adulteration within the meaning of Section 501(h) of the Federal Food; Drug and Cosmetic Act as documented by recurring violations. Future glove shipments are subject to refusal of admission pursuant to Section 801(a)(1). Non-violative analyses may not be sufficient to remove the appearance of a violation for manufacturers/shippers Level 3 Detention. Notes: *** Level 3 (8/1/2000)Note

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_229.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/).