FDA PRODUCT CODE · CLASS I
LZC — Medical Glove, Specialty
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
510(K)
SPEQ READINGA premarket notification under 21 CFR Part 807 Subpart E is the route for this code. The submission argues substantial equivalence to a legally marketed predicate, so the engineering question is which predicate the design can actually be compared against, and the evidence question is what testing supports that comparison.
Class I (low to moderate risk): general controls
SPEQ READINGGeneral controls carry the whole regulatory burden here — registration, listing, labelling, adverse-event reporting and prohibitions against adulteration and misbranding.
Device is eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGMalfunctions for this code may be reported in periodic summary form rather than as individual MDRs under 21 CFR Part 803. Eligibility is a property of the product code; using it is a decision the manufacturer makes and must be able to justify.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is not implantable
SPEQ READINGNo implant-specific expectations attach from the classification itself.
Device is not used for life sustaining purposes
SPEQ READINGNo life-sustaining designation attaches to this code.
Device is a candidate for a third party review program
SPEQ READINGAn Accredited Person may conduct the 510(k) review instead of FDA. FDA still makes the clearance decision — third-party review changes who reviews, never who decides.
Other product codes under 21 CFR 880.6250
One regulation usually governs several product codes. These share this code’s regulation, and therefore its classification basis.
21 CFR 880.6250 — Non-powdered patient examination glove
The classification regulation for this product code, as published by the Office of the Federal Register. This is the regulation text itself — no SPEQ interpretation appears in it.
(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]
Source: Electronic Code of Federal Regulations, Title 21. 21 CFR is a work of the United States Government and is in the public domain. SPEQ read this section on October 22, 2026. CFR is amended continuously, so verify against the source before acting on it: read 21 CFR 880.6250 on eCFR →
Recent clearances
Recent recalls
All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →