10xAnd
Scoping review

FDA product code · General Hospital · Class 1

KGO: Surgeon'S Gloves

KGO is FDA's product code for "Surgeon'S Gloves": a Class 1 device classified under 21 CFR 878.4460, reviewed by the General Hospital panel.

510(k) review time for KGO

Across 72 510(k) clearances under KGO decided from 2018-01-01 to 2026-10-06, the median was 171 days from FDA receipt to decision. Half took between 116 and 242 days, and 80% were decided within 251 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, KGO, decisions 2018-01-01 to 2026-10-06 (n = 72)
Fastest59
25th percentile116
Median171
75th percentile242
80th percentile251
90th percentile319
Slowest602
Median days by decision year, KGO (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20181947
201920411
202011715
202119914
20221276
202318514

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

KGO in the public FDA record

Records naming KGO, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years560
Device recalls44
Establishment listings820
GUDID device identifiers2,513

Counts of records, not of devices or events. Adverse event reports for KGO are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite KGO

12 FDA recognized consensus standards cite KGO, 4 of them recognized only in part, among them ANSI ASQ Z1.4-2003 (R2018); ASTM D6978-05(2023); ASTM D6124-06(2022). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 5-62 ANSI ASQ Z1.4-2003 (R2018) — Sampling Procedures and Tables for Inspection by Attributes
  • 6-147 ASTM D6978-05(2023) — Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
  • 6-178 ASTM D6124-06(2022) (partial recognition) — Standard Test Method for Residual Powder on Medical Gloves
  • 6-214 ASTM D6355-07(2022) — Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
  • 6-401 ASTM D7160-16 (Reapproved 2023) — Standard Practice for Determination of Expiration Dating for Medical Gloves
  • 6-411 ASTM D6499-18 — Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
  • 6-424 ASTM D5151-19(2023) — Standard Test Method for Detection of Holes in Medical Gloves
  • 6-443 ASTM D3577-19 (Reapproved 2023) (partial recognition) — Standard Specification for Rubber Surgical Gloves
  • 6-444 ASTM D7103-19(2023) — Standard Guide for Assessment of Medical Gloves
  • 6-496 ASTM F739-20 (partial recognition) — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
  • 6-497 ASTM D7866-23 (partial recognition) — Standard Specification for Radiation Attenuating Protective Gloves
  • 6-515 ASTM D6499-24 — Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

Related product codes