Atlas FDA

Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)

FDA 510(k) clearance K200897 · decided 2020-06-01

Clearance details

K-number
K200897
Device name
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
Applicant
Hartalega Sdn Bhd
Decision
Substantially Equivalent
Date received
2020-04-03
Decision date
2020-06-01
Days to decision
59 days
Clearance type
Traditional
Product code
KGO
Device class
1
Regulation number
878.4460
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Bandar Sri Damansara, MY
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.