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
Ifosfamide (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

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 is provided in blue. It meets all the requirements of ASTM D6319-10. 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 per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically non-sterile examination gloves tested for use with chemotherapy drugs. It is a declaration of substantial equivalence to a predicate device and therefore does not include a study to "prove the device meets acceptance criteria" in the way a clinical trial or algorithm validation study would. Instead, it presents information to demonstrate that the new device shares similar characteristics and performs comparably to a device already legally marketed.

Here's an analysis based on the information provided, framed to address your request for acceptance criteria and study details where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that for this type of device (patient examination gloves), "acceptance criteria" primarily relate to compliance with established industry standards for glove properties and permeation resistance. The document doesn't explicitly state numerical acceptance criteria for all aspects in a centralized table, but rather implies compliance with ASTM standards and compares performance to a predicate device.

However, we can extract the key performance metrics and their "acceptance" (or rather, "demonstrated") values, particularly for chemotherapy drug permeation resistance.

Category	Acceptance Criteria (Implied by Standards & Predicate)	Reported Device Performance (Subject Device)
General Glove Standards	Compliance with ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)	Meets all requirements of ASTM D6319-10.
Chemotherapy Drug Permeation	Permeation resistance as per ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs)	Carmustine (BCNU) (3.3 mg/ml): Permeation time: 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. Ifosfamide (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: 13.6 minutes. Vincristine Sulfate (1.0 mg/ml): Permeation time: no breakthrough up to 240 minutes. Important Note: Labeling indicates "DO NOT USE WITH CARMUSTINE OR THIOTEPA" due to their extremely low permeation times.
Material	Nitrile	Nitrile
Biocompatibility	Not a primary irritant and not a contact sensitizer.	Not a primary irritant and not a contact sensitizer under conditions of the study.

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

This document describes a medical device, which is a physical product (gloves). The "test set" in this context refers to the samples of gloves subjected to various physical and chemical tests, not a dataset for an AI algorithm.

Sample Size: Not explicitly stated as a single number. However, the use of standards like ASTM D6319-10, ASTM D6978-05, ASTM D5151-06, ISO 2859-1 (for sampling procedures), ASTM D412-16, ASTM D3767-03, and ASTM D573-04 implies that samples were chosen and tested in accordance with the methodologies prescribed by these standards, which define specific sample sizes for their respective tests (e.g., number of gloves for permeation, tensile strength, barrier integrity, etc.).
Data Provenance: The document states the device is manufactured by "SEMPERIT INVESTMENTS ASIA PTE. LTD." located in Singapore and mentions "Made in Malaysia" on the labeling. The testing was conducted to international (ISO) and U.S. (ASTM) standards. This indicates the testing was likely conducted in an approved laboratory, possibly in Malaysia or another location accredited to perform these tests to the specified standards. The data is prospective in the sense that the new device was specifically manufactured and tested to demonstrate its properties.

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

This question is not applicable to this type of device submission. There isn't "ground truth" established by human experts in the context of diagnostic imaging or clinical assessment. The "truth" here is determined by objective, measurable physical and chemical properties as defined by the ASTM and ISO standards for examination gloves and their resistance to chemicals.

4. Adjudication Method for the Test Set

Not applicable. Physical and chemical tests typically follow predefined protocols. The results are quantitative measurements or qualitative observations reported by the testing laboratory, not subject to human adjudication in the way medical diagnoses are.

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/software device. There are no "human readers" to compare performance with or without AI assistance.

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 device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device relies on:

Defined Standards: Compliance with physical, mechanical, and chemical resistance properties as outlined in the referenced ASTM and ISO standards (e.g., ASTM D6319-10 for general glove properties, ASTM D6978-05 for chemotherapy drug permeation).
Objective Measurement: Permeation times for chemotherapy drugs are determined through laboratory testing using established scientific methods, typically involving detection of the drug on the "inside" surface of the glove material after a certain exposure time. Similar objective measurements are used for tensile strength, barrier integrity, dimensions, etc.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 14, 2017

Semperit Investments Asia Pte. Ltd. % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K171378

Trade/Device Name: Non-Sterile, Single use. Powder-free examination glove tested for use with Chemotherapy drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: July 31, 2017 Received: August 8, 2017

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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171378

Device Name

Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs

Indications for Use (Describe)

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 Ifosfamide (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

DO NOT USE WITH CARMUSTINE OR THIOTEPA

Type of Use (Select one or both, as applicable)
	☑ Research Use Only (Part 21 CFR 201.26) - Select Disease:☑ For In Vitro Control Use Only (21 CFR 201.26)	☑ Research Use Only (Part 21 CFR 201.26) - Select Disease:	☑ For In Vitro Control Use Only (21 CFR 201.26)
☑ Research Use Only (Part 21 CFR 201.26) - Select Disease:
☑ For In Vitro Control Use Only (21 CFR 201.26)

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

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

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510k Summary for K171378

As required by 21 CFR 807.92

1- Date summary prepared: September 13, 2017

2- Owner/Submitter/Sponsor/Applicant information:

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

3- Device information:

Common/usual/classification name:

Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs.

Device name:

Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy Drugs.

FDA 3 letter code	LZA, LZC
FDA regulation number: 21 CFR	880.6250
Regulation medical specialty	General Hospital
Review panel	General Hospital
Class	I

4- Substantial equivalency is claimed against the following predicate device(s):

510k number	Trade or Proprietary or Model Name	Manufacturer
K083755	Non-Sterile, Powder-free Nitrile Examination glove,Lavender blue with Polymer coating, tested for usewith Chemotherapy Drugs	Siam Sempermed Corp, Ltd

5- Description of the device:

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Intended use + indications for use 6-

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

Do not use with Carmustine and Thiotepa.

7-Basis for a determination of substantial equivalency:
- (a) Indications for use:

The indication for use is identical to the predicate's, noting that our device covers all the drugs tested by predicate device, in addition to the following: Carmustine (BCNU), Cytarabine, Mitomycin C, Mitoxantrone and Thiotepa. These differences do not affectiveness of the subject device because testing of the additional drugs do not change the physical properties or function of the subject device.

(b) Technological characteristics:

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The technological characteristics are substantially equivalent to the predicate device, meeting the same technical standards.

	Subject device	Predicate Device	Comparison
Manufacturer	SEMPERIT INVESTMENTS ASIA PTE. LTD.	Siam Sempermed Corp., Ltd	N/A
510(k) number	K171378	K083755	N/A
Device trade or proprietary name	Non-Sterile, Powder-free Examinationglove, Blue, tested for use withChemotherapy Drugs	Non-sterile, Powder-Free Nitrile Examination Glove,Lavender Blue with Polymer Coating, Tested for Usewith Chemotherapy Drugs.	Different: our deviceis specified as blue,not lavender blue. Ourdevice does notinclude polymercoating
Device Classification Name/Regulation number	Patient Examination Glove21 CFR Part 880.6250	Patient Examination Glove21 CFR Part 880.6250	Same
Product Code	LZA, LZC	LZA, LZC	Same
Intended Use	This device is an ambidextrous patientexamination glove that is a non-sterile,single use, disposable device intended formedical purposes, worn on the examiner'shand or finger to prevent contaminationbetween patient and examiner. The testedchemotherapy drugs 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: nobreakthrough up to 240 minutesCyclophosphamide (Cytoxan) (20.0mg/ml). Permeation time: nobreakthrough up to 240 minutesCytarabine (100 mg/ml). Permeation time: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). Permeation time:no breakthrough up to 240 minutesFluorouracil (50.0 mg/ml). Permeationtime: no breakthrough up to 240 minutesIfosfamide (50.0 mg/ml). Permeation time: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). Permeationtime: no breakthrough up to 240 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.	Identical, except that the following drugs were nottested: Carmustine (BCNU), Cytarabine, Ifosfamide,Mitomycin C, Mitoxantrone and Thiotepa.NameCarmustine(BCNU) (3.3mg/ml)Cisplatin (1.0mg/ml)Cyclophosphamide (Cytoxan) (20.0mg/ml)Cytarabine (100mg/ml)Dacarbazine(DTIC) (10.0mg/ml)DoxorubicinHydrochloride(2.0 mg/ml)Etoposide (20.0mg/ml)Fluorouracil (50.0mg/ml)Ifosfamide (50.0mg/ml)Methotrexate(25.0 mg/ml)Mitomycin C (0.5mg/ml)Mitoxantrone(2.0 mg/ml)Paclitaxel (Taxol)(6.0 mg/ml)Thiotepa (10.0mg/ml)Vincristine Sulfate(1.0 mg/ml)	Break through timesNot testedno breakthrough up to240 minutesno breakthrough up to240 minutesNot testedno breakthrough up to240 minutesno breakthrough up to240 minutesno breakthrough up to240 minutesno breakthrough up to240 minutesNot testedno breakthrough up to240 minutesno breakthrough up to240 minutesNot testedno breakthrough up to240 minutesNot testedno breakthrough up to240 minutes	Similar

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Materials	Nitrile	Nitrile	Identical
Color	Blue	Lavender Blue	Different
Standards used	ISO 10993-10ASTM D6319-10ASTM D6124-06ASTM D5151-06ASTM D6978-05ISO 2859-1ASTM D412-16ASTM D3767-03ASTM D573-04	Same	Same
Non-Sterile, Single Use,disposable	Yes	Yes	Same
Packaging	Packed in Dispenser Boxes	Packed in Dispenser Boxes	Same
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 Thailand	Similar
Labeling Claim	Tested for Use with Chemotherapy Drugs	Tested for Use with Chemotherapy Drugs	Same
Biocompatibility	Not a primary irritant and not a contactsensitizer under conditions of the study	Not a primary irritant and not a contact sensitizerunder conditions of the study	Same

(c) Non-clinical tests- brief discussion:
The Non-clinical test results demonstrate the subject device has the same or similar physical and performance properties as the predicate device.
(d) Clinical tests- brief discussion:
Not applicable.
(e) The subject device K171378 Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy Drugs is as safe and as effective, and performs as well as or better than the predicate device K083755 Non-Sterile, Powder-Free Nitrile Examination glove, Lavender Blue with Polymer Coating, Tested for use with Chemotherapy Drugs.

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.