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FDA 510(k)

AspenMed+

K-Number: K213076 · 2021-12-20

ApplicantAspen Glove Sdn. Bhd.
Decision Date2021-12-20
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AspenMed+ is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2021-12-20 under 510(k) number K213076. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AspenMed+?

AspenMed+ is a medical device that received FDA 510(k) clearance on 2021-12-20. The listed applicant is Aspen Glove Sdn. Bhd.. The 510(k) number is K213076.

When did AspenMed+ receive FDA 510(k) clearance?

AspenMed+ received FDA 510(k) clearance on 2021-12-20, under 510(k) number K213076.

Who is the listed applicant for AspenMed+?

The FDA 510(k) record lists Aspen Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AspenMed+?

The FDA product code for AspenMed+ is LZC.

Other records listing Aspen Glove Sdn. Bhd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LZC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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