A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

Device Description

The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is a single use, disposable device made from a Nitrile Butadiene Rubber, blue in color, powder free and non-sterile (per 21 CFR Part 880.6250, class I). The device meets all the specifications in ASTM D6319-10. Standard specification for Nitrile Examination Gloves. Additionally, the gloves have been tested for biocompatibility and permeability to chemotherapy drugs.

The SHOWA® Blue Nitrile Powder Free Medical Examination Glove is designed to be used for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between the patient and the examiner (product code LZA). In addition, these gloves were tested for use with chemotherapy drugs (product code LZC) in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device, specifically the "SHOWA® Blue Nitrile Powder Free Medical Examination Glove." It outlines the acceptance criteria and the studies performed to demonstrate the device's substantial equivalence to a predicate device.

Here's the requested information:

1. A table of acceptance criteria and the reported device performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319-10 (Dimensions)	Demonstrate accurate sizing	Overall Length (mm): 220 mm (sizes XS – S) and 230 mm (sizes M - XL) Width (± 10 mm): Size XS = 70 mm, Size S = 80 mm, Size M = 95 mm, Size L = 110 mm, Size XL = 120 mm Thickness at Palm (mm): 0.05 min. Thickness at Finger Tip (mm): 0.05 min.	Pass
ASTM D6319-10 (Tensile Properties)	Demonstrate tensile conforming properties	Before Aging (D 412): Tensile Strength (MPa) = 14 min Ultimate Elongation (%) = 500 min. After Aging (D 573) (70°C ± 2°C for 166 hrs ± 2 hrs.): Tensile Strength (MPa) = 14 min Ultimate Elongation (%) = 400 min	Pass
ASTM D6319-10 (Freedom from Holes)	Demonstrate glove integrity	Freedom from Holes (D 5151): AQL 2.5 Inspection Level G-1	Pass
ASTM D6319-10 (Residual Powder)	Demonstrate biocompatibility: Residual powder	Residual Powder (D 6124): ≤ 2.0 mg/pc	Pass
Primary Skin Irritation Test ISO 10993-10	Demonstrate biocompatibility: Skin irritation	Under the conditions of the study, Not a primary skin irritant.	Pass
Dermal Sensitization Assay ISO 10993-10	Demonstrate biocompatibility: Skin sensitivity	Under the conditions of the study, Not a contact sensitizer.	Pass
Acute Systemic toxicity Study ISO 10993-11	Demonstrate biocompatibility: acute systemic toxicity	Under conditions of the ISO Acute Systemic Injection test, not toxic	Pass
Open box testing AAMI 11737-1	Demonstrate acceptable open box bioburden	Acceptable bioburden levels after 30 days open box.	Pass
ASTM D6978-05 (Chemo Permeation)	Resistance against Chemotherapy Drugs (permeation time)	Breakthrough greater than 240 min. for: Blenoxane, Busulfan, Carboplatin, Cisplatin, Cyclophosphamide, Cytarabine, Dacarbazine, Daunorubicin HCl, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Etoposide, Fludarabine, Fluorouracil, Gemcitabine, Idarubicin HCl, Ifosfamide, Irinotecan, Mechlorethamine HCl, Melphalan, Methotrexate, Mitomycin C, Mitoxantrone, Paclitaxel, Rituximab, Trisenox, Vincristine Sulfate. Breakthrough at 73.7 min. for: Carmustine (Warning: Do not use) Breakthrough at 25.4 min. for: ThioTepa (Warning: Do not use)	All tested drugs met or exceeded the specified breakthrough times. (Carmustine and ThioTepa had specific breakthrough times below 240 mins, with warnings not to use).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for dimensions, tensile strength, or chemotherapy permeation). It references specific ASTM and ISO standards for testing, which typically define the appropriate sample sizes and testing methodologies. The data provenance (country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. The "ground truth" for medical gloves is established by quantitative laboratory testing against defined material and performance standards (ASTM, ISO). There are no human experts judging images or clinical outcomes in this context.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiology reads) to resolve disagreements. Here, the "truth" is determined by objective physical and chemical testing.

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

This is not applicable. MRMC studies are typically performed for AI-powered diagnostic devices that assist human readers. This submission is for a physical medical device (examination glove).

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

This is not applicable. There is no algorithm involved; it is a physical device.

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

The "ground truth" for the device's performance is based on established industry standards and laboratory testing results. Specifically:

Dimensions, Physical Properties (Tensile Strength, Elongation), Freedom from Holes, Residual Powder: Defined by the ASTM D6319-10 standard.
Biocompatibility (Skin Irritation, Dermal Sensitization, Acute Systemic Toxicity): Defined by ISO 10993-10 and ISO 10993-11 standards.
Resistance against Chemotherapy Drugs: Defined by ASTM D6978-05 standard.
Open box bioburden: Defined by AAMI 11737-1.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The performance is assessed through direct testing of the product.

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

This is not applicable as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

January 19, 2022

Showa Best Glove, Inc. Jeffrey Richardson Director of Operations 579 Edison Street Menlo, Georgia 30731

Re: K211003

Trade/Device Name: SHOWA® Blue Nitrile Powder Free Medical Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: December 8, 2021 Received: December 9, 2021

Dear Jeffrey Richardson:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211003

Device Name

SHOWA®Blue Nitrile Powder Free Medical Examination Glove

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

Chemotherapy Drugs and Concentration Minimum breakthrough detection time (Min) ug/cm2/min Chemotherapy Drug and concentration Minimum Breakthrough, detection time in minutes, minutes 1) Blenoxane (15.0 mg/ml) 15,000 ppm >240 minutes 2) Busulfan (6.0 mg/ml) 6,000 ppm >240 minutes 3) Carboplatin (10.0 mg/ml) 10,000 ppm >240 minutes 4) Carmustine (3.3 mg/ml) 3,300 ppm 73.7 minutes 5) Cisplatin (1.0 mg/ml) 1,000 ppm >240 minutes 6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm >240 minutes 7) Cytarabine (100.0 mg/ml) 100,000 ppm >240 minutes 8) Dacarbazine (10.0 mg/ml) 10,000 ppm >240 minutes 9) Daunorubicin HCl (5.0 mg/ml) 5,000 ppm >240 minutes 10) Docetaxel (10.0 mg/ml) 10,000 ppm >240 minutes l 1) Doxorubicin HCl (2.0 mg/ml) 2,000 ppm >240 minutes 12) Epirubicin HCl (2.0 mg/ml) 2,000 ppm >240 minutes 13) Etoposide (20.0 mg/ml) 20,000 ppm >240 minutes 14) Fludarabine (25.0 mg/ml) 25.000 ppm >240 minutes 15) Fluorouracil (50.0 mg/ml 50,000 ppm >240 minutes 16) Gemcitabine (38.0 mg/ml) 38,000 ppm >240 minutes 17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm >240 minutes 18) Ifosfamide (50.0 mg/ml) 50,000 ppm >240 minutes 19) Irinotecan (20.0 mg/ml) 20,000 ppm >240 minutes 20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm >240 minutes 21) Melphalan (5.0 mg/ml) 5,000 ppm >240 minutes 22) Methotrexate (25.0 mg/ml) 25,000 ppm >240 minutes 23) Mitomycin C (0.5 mg/ml) 500 ppm >240 minutes 24) Mitoxantrone (2.0 mg/ml) 2,000 ppm >240 minutes 25) Paclitaxel (6.0 mg/ml) 6,000 ppm >240 minutes 26) Rituximab (10.0 mg/ml) 10,000 ppm >240 minutes 27) ThioTepa (10.0 mg/ml)10,000 ppm 25.4 minutes 28) Trisenox (1.0 mg/ml) 1,000 ppm >240 minutes 29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm >240 minutes The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.

. ..

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Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K211003 DATE OF PREPARATION: January 14, 2022

I. SUBMITTER

Showa Best Glove, Inc. 579 Edison Street Menlo. GA 30731 Tel: 706-862-6740 Fax: 706-862-6000

II. OFFICIAL CORRESPONDENCE/CONTACT PERSON

Jeffrey Richardson Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: 706-862-6740 Fax: 706-862-6000 Email: Bmoseley@showagroup.com

III. 510(K) PREPARER

Brian Moseley Showa Best Glove, Inc. 579 Edison Street Menlo, GA 30731 Tel: 706-862-6752 Fax: 706-862-2660 Email: Bmoseley@showagroup.com

IV.PROPOSED DEVICE

Trade Name/Proprietary Name: SHOWA® Blue Nitrile Powder Free Medical Examination Glove Common or Usual Name: Nitrile Patient Examination Glove Classification Name: Patient Examination Glove Regulation: 21 CFR 880.6250 Device Classification: Class: I Product Code: LZA, LZC

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V. PREDICATE DEVICE

Device Classification Name: Polymer Patient Examination Glove 510(k) Number: K200581 Product Code: LZA, LZC Applicant: Hartelega NGC SDN.BHD. Kawasan Perindustrian Tanjung Sepang, MY 43900

VI.DEVICE DESCRIPTION

VII. INDICATIONS FOR USE

A patient examination qlove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

These gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by chemotherapy drugs.

Chemotherapy Drug and concentration	Minimum Breakthrough, detectiontime in minutes, minutes
1) Blenoxane (15.0 mg/ml) 15,000 ppm	>240
2) Busulfan (6.0 mg/ml) 6,000 ppm	>240
3) Carboplatin (10.0 mg/ml) 10,000 ppm	>240
4) Carmustine (3.3 mg/ml) 3,300 ppm	73.7
5) Cisplatin (1.0 mg/ml) 1,000 ppm	>240
6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm	>240
7) Cytarabine (100.0 mg/ml) 100,000 ppm	>240
8) Dacarbazine (10.0 mg/ml) 10,000 ppm	>240
9) Daunorubicin HCI (5.0 mg/ml) 5,000 ppm	>240
10) Docetaxel (10.0 mg/ml) 10,000 ppm	>240
11) Doxorubicin HCI (2.0 mg/ml) 2,000 ppm	>240
12) Epirubicin HCI (2.0 mg/ml) 2,000 ppm	>240
13) Etoposide (20.0 mg/ml) 20,000 ppm	>240
14) Fludarabine (25.0 mg/ml) 25,000 ppm	>240

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15) Fluorouracil (50.0 mg/ml 50,000 ppm	>240
16) Gemcitabine (38.0 mg/ml) 38,000 ppm	>240
17) Idarubicin HCl (1.0 mg/ml) 1,000 ppm	>240
18) Ifosfamide (50.0 mg/ml) 50,000 ppm	>240

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19) Irinotecan (20.0 mg/ml) 20,000 ppm	>240
20) Mechlorethamine HCl (1.0 mg/ml) 1,000 ppm	>240
21) Melphalan (5.0 mg/ml) 5,000 ppm	>240
22) Methotrexate (25.0 mg/ml) 25,000 ppm	>240
23) Mitomycin C (0.5 mg/ml) 500 ppm	>240
24) Mitoxantrone (2.0 mg/ml) 2,000 ppm	>240
25) Paclitaxel (6.0 mg/ml) 6,000 ppm	>240
26) Rituximab (10.0 mg/ml) 10,000 ppm	>240
27) ThioTepa (10.0 mg/ml)10,000 ppm	25.4
28) Trisenox (1.0 mg/ml) 1,000 ppm	>240
29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm	>240

The maximum testing time is 240 minutes. Warning: Do not use with Carmustine or ThioTepa.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VIII.

	Proposed Device		Predicate Device		Comparison
Characteristics	SHOWA® Blue Nitrile Powder Free MedicalExamination Glove K211003		Polymer Patient Examination Glove510(k) Number K200581
DeviceDescription/RegulationNumber	Patient examination glove 21 CFR § 880.6250		Patient examination glove 21 CFR §880.6250		Same
Product Code	LZA, LZC		LZA, LZC, QDO		Similar
Indications forUse	A patient examinationglove is a disposabledevice intended formedical purposes that isworn on the examiner'shands or fingers toprevent contaminationbetween patient andexaminer.These gloves weretested for use withchemotherapy drugs inaccordance with ASTMD6978-05 StandardPractice for Assessmentof Medical Glove toPermeation bychemotherapy drugs.Chemotherapy Drugs andConcentration1) Blenoxane (15.0 mg/ml)15,000 ppm2) Busulfan (6.0 mg/ml) 6,000ppm3) Carboplatin (10.0 mg/ml)10,000 ppm4) Carmustine (3.3 mg/ml)3,300 ppm	MinimumBreakthrough,detection time inminutes, minutes>240 minutes>240 minutes>240 minutes73.7 minutes	Biodegradable Nitrite Powder FreeExamination Gloves Tested for Use withChemotherapy Drugs and FentanylCitrate (Blue) is a non-sterile disposabledevice intended for medical purpose thatis worn on the examiner's hand to preventcontamination between patient andexaminer. It is also tested to be usedagainst Chemotherapy Drugs andFentanyl Citrate, These gloves weretested for use with chemotherapy drugsand Fentanyl Citrate as per ASTMD6978-05 (Reapproved 2013) StandardPractice for Assessment of MedicalGloves to Permeation by ChemotherapyDrugs.Chemotherapy Drug andConcentrationCarmustine (3.3 mg/ml)Cisplatin (1.0 mg/ml)Cyclophosphamide (20.0mg/ml)Dacarbazine (10.0 mg/ml)Doxorubicin Hydrochloride(2.0 mg/ml)Etoposide (20.0 mg/ml)Fluorouracil (50.0 mg/ml)Methotrexate (25.0 mg/ml)	MinimumBreakthroughDetectionTime inMinutes21.4>240>240>240>240>240>240>240	Similar

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5) Cisplatin (1.0 mg/ml) 1,000 ppm	>240 minutes	Paclitaxel (6.0 mg/ml)	>240
6) Cyclophosphamide (20.0 mg/ml) 20,000 ppm	>240 minutes	Thiotepa (10.0 mg/ml)	67.2
7) Cytarabine (100.0 mg/ml)	>240 minutes	Vincristine Sulfate (1.0 mg/ml)	>240
		Azacytidine (25.0 mg/ml)	>240

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	100,000 ppm
	8) Dacarbazine (10.0 mg/ml)10,000 ppm	>240 minutes	Carboplatin (10.0 mg/ml)	>240
	9) Daunorubicin HCI (5.0 mg/ml) 5,000 ppm	>240 minutes	Docetaxel (10 mg/ml)	>240
	10) Docetaxel (10.0 mg/ml) 10,000 ppm	>240 minutes	Epirubicin (2.0 mg/ml)	>240
	11) Doxorubicin HCI (2.0 mg/ml) 2,000 ppm	>240 minutes	Gemcitabine (38 mg/ml)	>240
	12) Epirubicin HCI (2.0 mg/ml) 2,000 ppm	>240 minutes	Ifosfamide (50 mg/ml)	>240
	13) Etoposide (20.0 mg/ml) 20,000 ppm	>240 minutes	Irinotecan (20 mg/ml)	>240
	14) Fludarabine (25.0 mg/ml) 25,000 ppm	>240 minutes	Mitoxantrone (2.0 mg/ml)	>240
	15) Fluorouracil (50.0 mg/ml 50,000 ppm	>240 minutes	Oncovin (1.0 mg/ml)	>240
	16) Gemcitabine (38.0 mg/ml) 38,000 ppm	>240 minutes	Oxaliplatin (5 mg/ml)	>240
	17) Idarubicin HCI (1.0 mg/ml) 1,000 ppm	>240 minutes	Vinorelbine () 0 mg/ml)	>240
	18) Ifosfamide (50.0 mg/ml) 50,000 ppm	>240 minutes	Please note that Carmustine and Thiotepa have extremely low penetration times of 21.4 minutes and 67.2 minutes respectively.Warning: Do not use with Carmustine
	19) Irinotecan (20.0 mg/ml) 20,000 ppm	>240 minutes
	20) Mechlorethamine HCI (1.0 mg/ml) 1,000 ppm	>240 minutes
	21) Melphalan (5.0 mg/ml) 5,000 ppm	>240 minutes
	22) Methotrexate (25.0 mg/ml) 25,000 ppm	>240 minutes
	23) Mitomycin C (0.5 mg/ml) 500 ppm	>240 minutes	Fentanyl Citrate andConcentration	MinimumBreakthroughDetection Timein Minutes
	24) Mitoxantrone (2.0 mg/ml) 2,000 ppm	>240 minutes
	25) Paclitaxel (6.0 mg/ml) 6,000 ppm	>240 minutes
	26) Rituximab (10.0 mg/ml) 10,000 ppm	>240 minutes	Fentanyl Citrate Injection(100 mcg/2ml)	>240
	27) ThioTepa (10.0 mg/ml)10,000 ppm	25.4 minutes
	28) Trisenox (1.0 mg/ml) 1,000 ppm	>240 minutes
	29) Vincristine Sulfate (1.0 mg/ml) 1,000 ppm	>240 minutes
	The maximum testing time is 240 minutes.Warning: Do not use with Carmustine or ThioTepa.
Material Use	Nitrile		Nitrile		Same
Color	Blue		Blue		Same
Sterility	Non-Sterile		Non-Sterile		Same
Dimensions	Meets ASTM D6319-10		Meets ASTM D6319-10		Same
PhysicalProperties	Meets ASTM D6319-10		Meets ASTM D6319-10		Same
Freedom fromHoles(D 5151)	AQL 2.5 Inspection Meets ASTM D5151-06		AQL 2.5 Inspection Meets ASTM D5151-06		Same
Residual Powder(D 6124)	Meets ASTM D6124-06		Meets ASTM D6124-06		Same
Biocompatibility	Biocompatibilitytest – PrimarySkin Irritation Test(ISO 10993-10)		Under the conditions of the study, not aprimary skin irritant.		Under the conditions of the study, not aprimary skin irritant.	Same

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Biocompatibilitytest – DermalSensitizationAssay (ISO10993-10)	Under conditions of the study, not a contactsensitizer	Under conditions of the study, not acontact sensitizer	Same
Biocompatibilitytest – Acute	Under conditions of the ISO Acute SystemicInjection test, not toxic	Under conditions of the ISO AcuteSystemic Injection test, not toxic	Same

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systemic toxicityStudy (ISO10993-11)
ResistanceagainstChemotherapyDrugs StandardsPractice forAssessment ofresistance ofMedical Glove toPermeation byChemotherapydrugsASTM D6978-5(2013)	Breakthrough greater than 240 min.• Blenoxane (15.0 mg/ml)• Busulfan (6.0 mg/ml)• Carboplatin (10.0 mg/ml)• Cisplatin (1.0 mg/ml)• Cyclophosphamide (20.0 mg/ml)• Cytarabine (100.0 mg/ml)• Dacarbazine (10.0 mg/ml)• Daunorubicin HCI (5.0 mg/ml)• Docetaxel (10.0 mg/ml)• Doxorubicin HCI (2.0 mg/ml)• Epirubicin HCI (2.0 mg/ml)• Etoposide (20.0 mg/ml)• Fludarabine (25.0 mg/ml)• Fluorouracil (50.0 mg/ml)• Gemcitabine (38.0 mg/ml)• Idarubicin HCI (1.0 mg/ml)• Ifosfamide (50.0 mg/ml)• Irinotecan (20.0 mg/ml)• Mechlorethamine HCI (1.0 mg/ml)• Melphalan (5.0 mg/ml)• Methotrexate (25.0 mg/ml)• Mitomycin C (0.5 mg/ml)• Mitoxantrone (2.0 mg/ml)• Paclitaxel (6.0 mg/ml)• Rituximab (10.0 mg/ml)• Trisenox (1.0 mg/ml)• Vincristine Sulfate (1.0 mg/ml)Breakthrough at 73.7 min.Carmustine (3.3 mg/ml)Breakthrough at 25.4 min.ThioTepa (10.0 mg/ml)	Breakthrough greater than 240 min.• Cisplatin (1.0 mg/ml)• Cyclophosphamide (20.0 mg/ml)• Dacarbazine (10.0 mg/ml)• Doxorubicin Hydrochloride (2.0mg/ml)• Etoposide (20.0 mg/ml)• Fluorouracil (50.0 mg/ml)• Methotrexate (25.0 mg/ml)• Mitomycin C (0.5 mg/ml)• Paclitaxel (6.0 mg/ml)• Vincristine Sulfate (1.0 mg/ml)• Azacytidine (25.0 mg/m1)• Carboplatin (10.0 mg/ml)• Docetaxel (10 mg/ml)• Epirubicin (2.0 mg/ml)• Gemcitabine (38 mg/ml)• Ifosfamide (50 mg/ml)• Irinotecan (20 mg/ml)• Mitoxantrone (2.0 mg/ml)• Oncovin (1.0 mg/ml)• Oxaliplatin (5 mg/ml)• Vinorelbine (10 mg/ml)• Fentanyl Citrate (100 mcg/2ml)Breakthrough at 21.4 min.Carmustine (3.3 mg/ml)Breakthrough at 67.2 min.Thiotepa (10.0 mg/ml)	Similar

IX. SUMMARY OF NONCLINICAL TESTING

Test Method	Purpose	Acceptance Criteria	Results
ASTM D6319-10	Demonstrateaccurate sizing	DimensionsOverall Length (mm) =220 mm (sizes XS – S) and230 mm (sizes M - XL)Width (± 10 mm)Size XS = 70 mm Size S = 80 mm Size M = 95 mmSize L = 110 mm Size XL = 120 mmThickness at Palm (mm) = 0.05 min.Thickness at Finger Tip (mm) = 0.05 min.	Pass

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ASTM D6319-10	Demonstratetensileconformingproperties	Before Aging (D 412):Tensile Strength (MPa) = 14 minUltimate Elongation (%) = 500 min.	Pass
		After Aging (D 573) (70°C ± 2°C for 166 hrs ± 2 hrs.):Tensile Strength (MPa) = 14 minUltimate Elongation (%) = 400 min

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ASTM D6319-10	Demonstrateglove integrity	Freedom from Holes (D 5151)AQL 2.5 Inspection Level G-1	Pass
ASTM D6319-10	Demonstratebiocompatibility:Residual powder	Residual Powder (D 6124)≤ 2.0 mg/pc	Pass
Primary SkinIrritation TestISO 10993-10	Demonstratebiocompatibility:Skin irritation	Under the conditions of the study, Not a primary skinirritant.	Pass
DermalSensitizationAssayISO 10993-10	Demonstratebiocompatibility:Skin sensitivity	Under the conditions of the study, Not a contactsensitizer.	Pass
Acute Systemictoxicity StudyISO 10993-11	Demonstratebiocompatibility:acute systemictoxicity	Under conditions of the ISO Acute Systemic Injectiontest, not toxic	Pass
Open box testingAAMI 11737-1	Demonstrateacceptable openbox bioburden	Acceptable bioburden levels after 30 days open box	Pass

X. SUMMARY OF CLINICAL TESTING

No clinical testing was performed.

XI. CONCLUSION

The conclusions drawn from the non-clinical testing demonstrates that the SHOWA® Blue Nitrile Powder Free Medical Examination Glove is as safe, as effective, and performs as well or better than the legally marketed device (K200581).

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.