# K122999: Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Top Glove Sdn. Bhd.
- Decided: Nov 30, 2012 after 64 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Blue Powder Free Nitrile Examination Cloves Tested For Use With Chenmotherapy Drugs glove is a disposable device intended for medical purpose that is worn on the examiner's band or linger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical gloves to Permeation by Chemotherapy Drugs: Chemotherany Drug and Concentration — Minimum Breakthmough Detection time in Minutes, 0.01 up/an2lminut I slatin, 1.0 nglmIl (1,0oppm) >240' 2 Zcophospharnde (Cytmaan),2O.Omgiml (20,OO0pmn) >.24b 3 )acrbazin (DTIC);10.0 mng/oil (tO,OO0ppm) >240 4 ldHydrodilorlde, i-Omg/ml (ZOO00ppm) rauubci >240 5 toposide (Topcisar). 20.0 mg/nIJ (20,000)ppm >240 6 luo)radl, 50.0 mg/ml (50,OO0pprn) >240 7 adltaxel (Taxcol, 6.0 mng/rn!i (6,OO0ppm) >240 8 naustine (BCNU)3.3mg/ml(3,300ppl) 0.9 9 liotepa. 1.Omgjml C1,OO0ppm) 0.05 The maibximum testing timne is 240 mninutes. Pleaise note that the followsing drugs han extrveey low pereation time of less than 30 minutes Carmustlne (BCNU.)3.3mg/IK3,3009pm) Thlotepa, iO.Omgjml ( 1O,OO0ppm)

Source page: https://510kreport.com/device/K122999
Methodology: https://510kreport.com/methodology