The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL. The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.

AI/ML Overview

The document describes the non-clinical testing and acceptance criteria for the "Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove" (K190159). The study aimed to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (K082125).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Specification	Standard / Test Method	Reported Device Performance
Performance Standards	ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application	Conforms
	ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves	Conforms
	ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves	Conforms
	ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves	Conforms (Shelf Life: 3 years, as noted in the technological comparison table, and this standard supports that determination).
	ASTM D412-15a Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension	Conforms (Indicated by compliance with ASTM D6319-10, which includes physical property requirements like tension).
Water Tightness	ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves	Conforms
	ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application	Conforms
	ASTM D7160-16 Standard Practice for Determination of Expiration Dating for Medical Gloves	Conforms
Biocompatibility	ISO 10993-10 Skin Irritation Study	"Under the conditions of the study, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device is not a skin irritant."
	ISO 10993-10 Closed Patch Sensitization Study	"Under the conditions of the study, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device is not a contact sensitizer."
	ISO 10993-11 Acute Systemic Toxicity Study	"Under conditions of the ISO Acute Systemic Injection Test, the non-polar and polar device extracts did not elicit a response in the animal model. Therefore, the device does not present an acute toxicity potential."
Powder Residual	ASTM D6124-06 (acceptance criterion: <2mg/glove)	Meets ASTM D6124 of <2mg/glove
Physical Property	ASTM D6319-00 (Note: document mentions D6319-10 in other sections, but D6319-00 here)	Meets ASTM D6319-00 (This is from the comparison table, it seems to be an older version listed for the predicate, but the proposed device explicitly states it meets D6319-10 in the Summary of Non-Clinical Testing section, which encompasses physical properties). For consistency, the primary standard for the proposed device is D6319-10.

Note on ASTM D6319 versions: The "Technological Characteristic Comparison Table" lists "Meets ASTM D6319-00" for both predicate and proposed devices under "Physical Property." However, the "Summary of Non-Clinical Testing" for the proposed device explicitly lists "ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application" as a standard it conforms to. It's likely that compliance with D6319-10 (a newer version) supersedes or includes requirements from D6319-00.

2. Sample size used for the test set and the data provenance

The document refers to non-clinical testing based on various ASTM and ISO standards for medical gloves. These standards typically involve specific sampling plans and test methods for performance, water tightness, and biocompatibility.

Sample Size: The exact sample sizes for each test within the ASTM and ISO standards are not explicitly stated in this summary. These standards define the required sample sizes for tests such as water tightness (e.g., AQL levels), tensile properties, and force at break. For biocompatibility studies (ISO 10993), specific numbers of animal models are used per test, but are not detailed in this summary.
Data Provenance: The studies are described as "non-clinical testing" conducted to demonstrate conformity with recognized international standards (ASTM and ISO). This implies laboratory testing of the manufactured gloves. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, beyond it being a submission for premarket notification K190159 for a newly manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable to this device submission. This document pertains to the physical and biological performance testing of a medical exam glove, not a diagnostic device requiring expert interpretation of results to establish ground truth. The "ground truth" here is the objective measurement of the glove's properties against established standard specifications (e.g., tensile strength, freedom from holes, biocompatibility).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. As noted above, this involves objective physical and chemical testing against established standards, not interpretation by human adjudicators.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-enabled diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth is established by objective measurements and chemical/biological testing against pre-defined, standardized acceptance criteria outlined in the referenced ASTM and ISO standards (e.g., ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, ISO 10993-10, ISO 10993-11). For example, the "ground truth" for water tightness is the absence of holes when tested using the specified method; for biocompatibility, it's the lack of specified adverse biological responses in animal models.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set is used for this type of medical device submission.

Summary

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May 6, 2019

Showa Best Glove, Inc. % Lee Rosebush Attorney BakerHostetler 1050 Connecticut Avenue, NW, Suite 1100 Washington, District of Columbia 20036-5304

Re: K190159

Trade/Device Name: Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZC Dated: January 28, 2019 Received: January 31, 2019

Dear Lee Rosebush:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For David Krause, PhD Acting Director Division of Infection Control and Plastic Surgery Office of Surgical & Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health

Enclosure

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FOIA Exempt - Confidential and Trade Secret Information
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

Indications for Use

510(k) Number (if known)	K190159
Device Name	Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove
Indications for Use (Describe)	The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended formedical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K190159

Image /page/3/Picture/1 description: The image shows the SHOWA logo with the text "Revised 510(k) Date: March 26, 2019" underneath. The SHOWA logo is in black and green. The text is in black and is centered below the logo.

General Information

Submitter: I.

Name: Showa Best Glove, Inc. a.
b. Address: 579 Edison Street, Menlo, GA 30731-6335
Telephone Number: 706-862-6712 C.
d. Fax Number: 706-862-6000
Contact Person: Jeffrey Richardson e.
f. FDA Owner/Operator Number: 9041216

Name of Device: II.

Trade or Proprietary Name: Showa® Medical Exam Glove (Green) Powder-free, a. Disposable Nitrile Gloves
b. Common or Usual Name: Polymer Patient Exam Gloves
Classification Name: Patient Examination Glove (LZA, 21 C.F.R. § 880.6250) C.
d. 510(k) Submission Number: K190159

III. Predicate Device:

a. Name: N-DEX NightHawk® Black Nitrile Powder-Free Medical Examination Glove (Black), Non-Sterile
b. Submission Number: K082125

IV. Description of Device:

The Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent

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contamination between patient and examiner. The gloves are single use only, supplied in a nonsterile state, and come in six (6) sizes: XS, S, M, L, XL, and XXL.

The gloves are made of Nitrile Butadiene Rubber, designed, and manufactured in accordance with ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application.

Their physical and performance characteristics meet all requirements of ASTM D6319-10. The gloves are powder-free and meet the requirements of ASTM D6124-06. No powder is used during any stage of manufacturing. Rather, the gloves are manufactured using online chlorination - a process wherein the examination gloves are dipped in a dilute chlorine solution to reduce surface friction. More specifically, through the chlorination reaction, the compound is stabilized and further cross-linked and the gloves' surface becomes hardened and smooth, thereby providing the gloves with good donning properties. The gloves then are removed from the chlorination solution and neutralized in an aqueous ammonia solution and washed until any residual chlorine is removed, resulting in the gloves' surface pH being similar to that of water. Once the wash process is completed, the reactive material is removed, thus ceasing the chlorination process.

Characteristic	Predicate DeviceK082125	Proposed DeviceK190159	Comparison
	N-DEX NightHawk®Black Nitrile Powder-Free MedicalExamination Glove(Black), Non-Sterile	Showa® MedicalExam Glove(Green) powder-free, disposablenitrile gloves
Device Description/Regulation Number	Patient examinationglove/ 21 C.F.R. §880.6250	Patient examinationglove/ 21 C.F.R. §880.6250	Identical
Product Code	LZA	LZA	Identical
Intended Use	Intended for medicalpurposes that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer.	Intended for medicalpurposes that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer.	Identical

Technological Characteristic Comparison Table:

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Instructions for Use	A disposable deviceintended for medicalpurposes that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer.	A disposable deviceintended for medicalpurposes that is wornon the examiner'shand to preventcontaminationbetween patient andexaminer.	Identical
Materials	Nitrile	Nitrile	Identical
Color	Black	Green	Different
Single Use	Yes	Yes	Identical
Physical Property	Meets ASTM D6319-00	Meets ASTM D6319-00	Identical
Powder Residual	Meets ASTM D6124of <2mg/glove	Meets ASTM D6124 of<2mg/glove	Identical
Biocompatibility	Skin irritation Study(ISO 10993-10)	Skin irritation Study(ISO 10993-10)	Identical
	Closed PatchSensitization Study(ISO 10993-10)	Closed PatchSensitization Study(ISO 10993-10)	Identical
	Cytotoxic Study(ISO 10993-5)	/	Different
	/	Acute systemic toxicityStudy (ISO 10993-11)	Different
Shelf Life	N/A	3 years	Different
BiodegradationProperties	None	Biodegradable	Different

Summary of Difference and Comparison of Technological Characteristics- The subject device differs from the predicate in that:

. The subject device has biodegradation property within landfills tested per ASTM D5526 while the predicate device does not have same technological feature. The difference in biodegradation properties does not affect the subject device's safety and effectiveness; subject device met the requirements for Biocompatibility Testing and ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application. The difference in technological feature does not change the performance or affect the intended use of the device.
Biodegradability is not a medical claim and therefore was not reviewed by FDA. ●

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Summary of Non-Clinical Testing

Specification	Proposed Device K190159
	Showa® Medical Exam
	Glove (Green) Powderfree, Disposable Nitrile Glove
Performance Standards(conforms)	ASTM D6319-10 Standard Specification for Nitrile ExaminationGloves for Medical Application;
	ASTM D6124-06 Standard Test Method for Residual Powder onMedical Gloves;
	ASTM D5151-06 Standard Test Method for Detection of Holes inMedical Gloves;
	ASTM D7160-16 Standard Practice for Determination ofExpiration Dating for Medical Gloves;
	ASTM D412-15a Standard Test Methods for Vulcanized Rubberand Thermoplastic Elastomers—Tension
Water Tightness(conforms)	ASTM D5151-06 Standard Test Method for Detection of Holes inMedical Gloves;
	ASTM D6319-10 Standard Specification for Nitrile ExaminationGloves for Medical Application;
	ASTM D7160-16 Standard Practice for Determination ofExpiration Dating for Medical Gloves
Biocompatibility	Proposed Device K190159
	Showa® Medical Exam
	Glove (Green) Powder-free, Disposable Nitrile Glove
ISO Skinirritation Study(ISO 10993-10)	Under the conditions of the study, the non-polar and polar deviceextracts did not elicit a response in the animal model. Therefore, thedevice is not a skin irritant
ISO Closed PatchSensitization Study(ISO 10993-10)	Under the conditions of the study, the non-polar and polar deviceextracts did not elicit a response in the animal model. Therefore, thedevice is not a contact sensitizer
Acute Systemic ToxicityStudy (ISO 10993-11)	Under conditions of the ISO Acute Systemic Injection Test, the non-polar and polar device extracts did not elicit a response in the animalmodel. Therefore, the device does not present an acute toxicitypotential.

Conclusions:

Based on the Indication for Use, technological characteristics, and non-clinical performance data, Showa® Medical Exam Glove (Green) Powder-free, Disposable Nitrile Glove (K190159) is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K082125).

Regulation Number and Section

§ 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.