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Disinfectant, Medical Devices

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.6890
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6890 General purpose disinfectants

§ 880.6890 General purpose disinfectants.

(a) Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.

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

[65 FR 36326, June 8, 2000]

Disinfectant, Medical Devices

Page Type
Product Code
Regulation Medical Specialty
General Hospital
Review Panel
General Hospital
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
880.6890
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 880.6890 General purpose disinfectants

§ 880.6890 General purpose disinfectants.

(a) Identification. A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin.

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

[65 FR 36326, June 8, 2000]