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Fentanyl And Other Opioid Protection Glove

Page Type
Product Code
Definition
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Fentanyl and other opioid protection gloves are tested for use with chemotherapy drugs, Fentanyl Citrate, and possibly other opioids per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Physical State
Polymer examination medical glove
Technical Method
Device is worn on the hand
Target Area
Skin of the hand
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
880.6250
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6250 Non-powdered patient examination glove

§ 880.6250 Non-powdered patient examination glove.

(a) Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

(b) Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016; 84 FR 71815, Dec. 30, 2019]

Fentanyl And Other Opioid Protection Glove

Page Type
Product Code
Definition
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. Fentanyl and other opioid protection gloves are tested for use with chemotherapy drugs, Fentanyl Citrate, and possibly other opioids per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Physical State
Polymer examination medical glove
Technical Method
Device is worn on the hand
Target Area
Skin of the hand
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
880.6250
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6250 Non-powdered patient examination glove

§ 880.6250 Non-powdered patient examination glove.

(a) Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

(b) Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 54 FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016; 84 FR 71815, Dec. 30, 2019]