This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times: Carmustine: 14.7 minutes Thiotepa: 13.6 minutes Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA

Device Description

The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs and fentanyl is provided in blue. It meets all the requirements of ASTM D6319. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs as well as Fentanyl, per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. It can be available in 4 specifications: S, M, L and XL.

AI/ML Overview

The provided text is a 510(k) summary for a Nitrile Examination Glove. It details the device's characteristics, indications for use, and non-clinical testing conducted to support its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319	Dimensions	Length: ≥220mm (XS, S), ≥230mm (M, L, XL)Width: 70±10mm (XS), 80±10mm (S), 95±10mm (M), 110±10mm (L), 120±10mm (XL)Thickness (mm): Finger: ≥0.05, Palm: ≥0.05	Pass
ASTM D6319	Physical Properties	Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400%	Pass
ASTM D5151	Freedom from Holes	Shall comply with freedom from holes (AQL = 2.5)	Pass
ASTM D6124	Powder-free Residue	Powder residue limit of 2.0 mg	Pass
ISO 10993-10	To determine if the finished device material is an irritant.	Non-irritating	Pass (Not an irritant)
ISO 10993-10	To determine if the finished device material is a sensitizer.	Non-sensitizing	Pass (Not a sensitizer)
ASTM D6978	Resistance to permeation by Fentanyl	No breakthrough when tested for permeation with Fentanyl	Pass
ASTM D6978	Resistance to Permeation by Chemotherapy Drugs	No breakthrough (up to 240 minutes) for most listed drugs. Carmustine (BCNU) and Thiotepa had extremely low permeation times (14.7 and 13.6 minutes, respectively), leading to a warning not to use with these drugs.	Pass (based on specified permeation times)

2. Sample Size Used for the Test Set and the Data Provenance:

The document does not explicitly state the sample sizes used for each specific test in the test set. However, it indicates tests were conducted according to ASTM and ISO standards, which typically specify sampling plans. The data provenance is not mentioned, so we cannot determine the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is typically not applicable to studies for medical gloves, as the "ground truth" is established by direct physical, chemical, and biological testing against predefined scientific standards, not by expert consensus or review of diagnostic images.

4. Adjudication Method for the Test Set:

Not applicable, as the tests involve objective measurements against established standards, not interpretation by experts requiring adjudication.

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 a medical glove, not an AI-powered diagnostic or assistive device.

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

Not applicable. This is a medical glove, not an algorithm. The device performance is assessed through laboratory testing.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is based on objective measurements and chemical/physical assessments against established industry standards (ASTM and ISO). For example:

Dimensional measurements: Direct physical measurement.
Physical properties (Tensile strength, Elongation): Mechanical testing.
Freedom from holes: Water leak test as per ASTM D5151.
Powder-free residue: Gravimetric analysis as per ASTM D6124.
Biocompatibility (Irritation and Sensitization): Biological testing on animal models (typically as per ISO 10993-10).
Permeation by Fentanyl and Chemotherapy Drugs: Chemical permeation testing as per ASTM D6978, measuring breakthrough time.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 27, 2023

Semperit Investments Asia PTE. LTD. % Jay Mansour Regulatory Consultant / Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K223903

Trade/Device Name: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: December 27, 2022 Received: December 28, 2022

Dear Jay Mansour:

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/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 medical devices and radiation-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.

Allan G

For Bifeng Qian M.D., Ph. D. 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) K223903

Device Name Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE Indications for Use (Describe) This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times:

Carmustine: 14.7 minutes Thiotepa: 13.6 minutes

Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K223903- 510(k) summary

I Submitter

Device submitter: SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road, #29-03 To 06 The JTC Summit Singapore 609434

Contact person: Jay Mansour Mansour Consulting LLC Regulatory consultant Phone (678) 908-8180 Email jay@mansourconsulting.com
Date of preparation: January 27, 2023

II Proposed device

510(k) Number:	K223903
Trade/Device Name:	Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and FentanylSMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104)X-LARGE SIZE (NGPF105)
Regulation number:	21 CFR 880.6250
Regulation name:	Non-powdered Patient Examination Glove
Regulatory class:	Class I
Product code:	LZA (primary), LZC, OPJ, QDO
Review panel:	General Hospital

III Predicate devices

510(k) Number:	K171378
Trade/Device name:	Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs
Regulation number:	21 CFR 880.6250
Regulation name:	Non-powdered Patient Examination Glove
Regulatory class:	Class I

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Product code: LZA (primary), LZC SEMPERIT INVESTMENTS ASIA PTE. LTD. Manufacturer:

IV Device description

V Indications for use

The tested chemotherapy drugs are:

Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.

Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes

Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes

Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is:

Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes

Please note that the following drugs have extremely low permeation times:

Carmustine: 14.7 minutes

Thiotepa: 13.6 minutes

Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA

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VI Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization

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Testmethod	Purpose	Acceptance Criteria	Result
ASTMD6319	Dimensions	Extra-Small	Length: ≥220mm;Width: 70±10 mm
		Small	Length: ≥220mm;Width: 80±10mm
		Medium	Length: ≥230mm;Width: 95±10mm	Pass
		Large	Length: ≥230mm;Width: 110±10mm
		Extra- Large	Length: ≥230mm;Width: 120±10mm
		Thickness (mm):Finger: ≥0.05Palm: ≥0.05		Pass
	Physical properties	BeforeAging	TensileStrength ≥14MPaUltimateElongation ≥500%	Pass
		AfterAging	TensileStrength ≥14MPaUltimateElongation ≥400%	Pass

ASTMD5151	Freedom from holes	Shall comply with freedom from holes (AQL = 2.5)when tested in accordance with ASTM D5151.		Pass
ASTMD6124	Powder-free Residue	Have a powder residue limit of 2.0 mg inaccordance with ASTM D6124.		Pass
ISO10993-10	To determine if thefinished devicematerial is an irritant.	Non-irritating		Under the conditions ofthe study not an irritant/Pass
ISO10993-10	To determine if thefinished devicematerial is a sensitizer.	Non-sensitizing		Under conditions of thestudy, not a sensitizer. /Pass
	Resistance topermeation byFentanyl	No breakthrough when tested for permeation withFentanyl in accordance with ASTM D6978.		Pass
ASTMD6978	Resistance toPermeation byChemotherapy Drugs	Covered in predicate device 510(k) K171378 forCarmustine (BCNU) (3.3 mg/ml)Cisplatin (1.0 mg/ml)Cyclophosphamide (Cytoxan) (20.0 mg/ml)Cytarabine (100 mg/ml)Dacarbazine (DTIC) (10.0 mg/ml)Doxorubicin Hydrochloride (2.0 mg/ml)Etoposide (20.0 mg/ml)Fluorouracil (50.0 mg/ml)Ifosfamide (50.0 mg/ml)Methotrexate (25.0 mg/ml)Mitomycin C (0.5 mg/ml)Mitoxantrone (2.0 mg/ml)Paclitaxel (Taxol) (6.0 mg/ml)		Pass

Table 1 Summary of Non-Clinical Performance Testing

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	Vincristine Sulfate (1.0 mg/ml)Thiotepa (10.0 mg/ml)

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VII Clinical Test Conclusion

No clinical study is included in this submission.

VIII Summary of Technological characteristics

	Subject device	Predicate device	Comments
Manufacturer	SEMPERIT INVESTMENTS ASIA PTE. LTD.	SEMPERIT INVESTMENTS ASIA PTE. LTD.	N/A
510(k) number	TBD	K171378	N/A
Device trade orproprietary name	Non-Sterile, Single use, Powder-freeexamination glove, Blue, tested for usewith Chemotherapy drugs and fentanyl	Non-Sterile, Powder-free Examinationglove, Blue, tested for use withChemotherapy Drugs	Different: except the addition of Fentanyl forsubject device, it is identical
Device ClassificationName/ Regulation number	Patient Examination Glove21 CFR Part 880.6250	Patient Examination Glove21 CFR Part 880.6250	Identical
Product Code	LZA (primary), LZC, OPJ, QDO	LZA (primary), LZC	Different: added two product codes
Indications for use	This device is an ambidextrous patientexamination glove that is a non-sterile,single use, disposable device intendedfor medical purposes, worn on theexaminer's hand or finger to preventcontamination between patient andexaminer.The tested chemotherapy drugs are:Carmustine (BCNU) (3.3 mg/ml).Permeation time: Carmustine (BCNU)has extremely low permeation times of14.7 minutes.Cisplatin (1.0 mg/ml). Permeation time:no breakthrough up to 240 minutesCyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthroughup to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthroughup to 240 minutes Dacarbazine (DTIC)(10.0 mg/ml). Permeation time: nobreakthrough up to 240 minutesDoxorubicin Hydrochloride (2.0 mg/ml).Permeation time: no breakthrough up to240 minutesEtoposide (20.0 mg/ml). Permeationtime: no breakthrough up to 240minutes Fluorouracil (50.0 mg/ml).Permeation time: no breakthrough up to	This device is an ambidextrous patientexamination glove that is a non-sterile,single use, disposable device intendedfor medical purposes, worn on theexaminer's hand or finger to preventcontamination between patient andexaminer. The tested chemotherapydrugs are:Carmustine (BCNU) (3.3 mg/ml).Permeation time: Carmustine (BCNU) hasextremely low permeation times of 14.7minutes.Cisplatin (1.0 mg/ml). Permeation time:no breakthrough up to 240 minutesCyclophosphamide (Cytoxan) (20.0mg/ml). Permeation time: nobreakthrough up to 240 minutesCytarabine (100 mg/ml). Permeationtime: no breakthrough up to 240 minutesDacarbazine (DTIC) (10.0 mg/ml).Permeation time: no breakthrough up to240 minutesDoxorubicin Hydrochloride (2.0 mg/ml).Permeation time: no breakthrough up to240 minutesEtoposide (20.0 mg/ml). Permeationtime: no breakthrough up to 240 minutesFluorouracil (50.0 mg/ml). Permeationtime: no breakthrough up to 240 minutesIfosfamide (50.0 mg/ml). Permeationtime: no breakthrough up to 240 minutesMethotrexate (25.0 mg/ml). Permeationtime: no breakthrough up to 240 minutesMitomycin C (0.5 mg/ml). Permeationtime: no breakthrough up to 240 minutesMitoxantrone (2.0 mg/ml). Permeationtime: no breakthrough up to 240 minutesPaclitaxel (Taxol) (6.0 mg/ml).Permeation time: no breakthrough up to240 minutesThiotepa (10.0 mg/ml). Permeation time:Thiotepa has extremely low permeationtimes of 13.6 minutesVincristine Sulfate (1.0 mg/ml).Permeation time: no Breakthrough up to240 minutes.DO NOT USE WITH CARMUSTINE ORTHIOTEPA	DifferentSubject device includes Fentanyl, whilepredicate device does not. Other than forFentanyl, the indications for use are identical.Note: Adding the Fentanyl to the indicationdoes not affect the intended use. The device'sintended use is it would be worn on the handfor medical purposes to provide a barrieragainst potentially infectious materials andother contaminants. Therefore, there are nodifferences to the intended therapeutic,diagnostic, prosthetic, or surgical use of thedevice, and therefore the change in theindication for use (by adding Fentanyl) doesnot affect the safety and effectiveness of thedevice when used as labeled.
Materials	Nitrile	Nitrile	Identical

Standards used	1. ISO 10993-102. ASTM D6319-193. ASTM D6124-06 (reapproved 2017)4. ASTM D5151-195. ASTM D6978-05 (reapproved 2019)6. ISO 2859-17. ASTM D412-16e18. ASTM D3767-03 (2020)9. ASTM D573-04 (2019)	1. ISO 10993-102. ASTM D6319-10 (reapproved 21015)3. ASTM D6124-06 (2011)4. ASTM D5151-065. ASTM D6978-05 (re-approved 2013)6. ISO 2859-17. ASTM D412-168. ASTM D3767-03 (2014)9. ASTM D573-04 (2015)	Identical, with justification provided below, following the same numbering sequence:1. See biocompatibility below2. The changes did not affect product design, production and compliance(1st change: section 1.5. 2nd change: adding calculation options instead of actual cutting. 3rd change: limitation on accelerated aging option based on natural aging. 4th change: size XXL is introduced in the revised standard BUT it is NOT added in this submission). Recognition number is updated from 6-244 to 6-446
			3. No changes in the standard.Recognition number 6-178 remains the same.
			4. The changes did not affect product design, production and compliance(1st change: section 1.7. 2nd change: temperature of the water leak test). Recognition number is updated from 6-175 to 6-424
			5. No change in the standard. Recognition number 6-147 remains the same
			6. No change in the standard. Recognition number was updated from 5-62 to 5-88
			7. No changes in the standard. Version D412-16 was accepted in 510k submissions without recognition number. D412-16e1 is now recognized under recognition number 8-559.
			8. No changes in the standard. Standard accepted in 510k submissions but still not having a recognition number.
			9. No changes in the standard. Standard accepted in 510k submissions but still not having a recognition number.
Non-Sterile, Single Use, disposable	Yes	Yes	Identical
Packaging	Packed in Dispenser Boxes	Packed in Dispenser Boxes	Identical
Labeling Features	Non-SterilePowder FreeExamination GlovesAmbidextrous, by SizeSingle use onlyDevice ColorManufactured for:Lot Number:Quantity by WeightMade in Malaysia	Non-SterilePowder FreeExamination GlovesAmbidextrous, by SizeSingle use onlyDevice ColorManufactured for:Lot Number:Quantity by WeightMade in Malaysia	Identical
Labeling Claim	Tested for Use with Chemotherapy Drugs and Fentanyl	Tested for Use with Chemotherapy Drugs	Identical except for the addition of Fentanyl, which is the subject of this submission
Biocompatibility	Sensitization and irritation compliant asper ISO 10993-10	Sensitization and irritation compliant asper ISO 10993-10	Identical based on recognition number 2-174covering sensitization and irritation in thesame standard

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IX Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission K223903, Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs , cleared under 510(k) K171378.

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.