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

K171378 · Semperit Investments Asia Pte , Ltd. · LZA · Sep 14, 2017 · General Hospital

Device Facts

• Record ID: K171378
• Device Name: Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
• Applicant: Semperit Investments Asia Pte , Ltd.
• Product Code: LZA · General Hospital
• Decision Date: Sep 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

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

Device Story

Ambidextrous, non-sterile, single-use, blue nitrile examination glove; worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05. Device provides a physical barrier; does not include polymer coating. Used in clinical settings; provides protection during handling of chemotherapy agents, excluding specific drugs with low permeation times (Carmustine, Thiotepa).

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via ASTM D6978-05 for chemotherapy drug permeation and ASTM D6319-10 for physical properties.

Technological Characteristics

Material: Nitrile. Form: Ambidextrous, blue, powder-free, single-use. Standards: ASTM D6319-10, ASTM D6978-05, ASTM D6124-06, ASTM D5151-06, ASTM D412-16, ASTM D3767-03, ASTM D573-04, ISO 10993-10, ISO 2859-1. Biocompatibility: Non-irritant, non-sensitizer.

Indications for Use

Indicated for use as an ambidextrous, non-sterile, single-use, disposable patient examination glove worn on the examiner's hand or finger to prevent cross-contamination between patient and examiner. Tested for use with specific chemotherapy drugs; do not use with Carmustine or Thiotepa.

Regulatory Classification

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.

Predicate Devices

• Non-Sterile, Powder-free Nitrile Examination glove, Lavender blue with Polymer coating, tested for use with Chemotherapy Drugs (K083755)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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

| Type of Use (Select one or both, as applicable) | | | |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | <table style="border: none;"><tr><td><span style="font-size: 10px;">☑</span> Research Use Only (Part 21 CFR 201.26) - Select Disease:</td></tr><tr><td><span style="font-size: 10px;">☑</span> For <i>In Vitro</i> Control Use Only (21 CFR 201.26)</td></tr></table> | <span style="font-size: 10px;">☑</span> Research Use Only (Part 21 CFR 201.26) - Select Disease: | <span style="font-size: 10px;">☑</span> For <i>In Vitro</i> Control Use Only (21 CFR 201.26) |
| <span style="font-size: 10px;">☑</span> Research Use Only (Part 21 CFR 201.26) - Select Disease: | | | |
| <span style="font-size: 10px;">☑</span> For <i>In Vitro</i> 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,<br>Lavender blue with Polymer coating, tested for use<br>with Chemotherapy Drugs | Siam Sempermed Corp, Ltd |

# 5- Description of the device:

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.

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#### Intended use + indications for use 6-

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

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 Examination<br>glove, Blue, tested for use with<br>Chemotherapy Drugs | Non-sterile, Powder-Free Nitrile Examination Glove,<br>Lavender Blue with Polymer Coating, Tested for Use<br>with Chemotherapy Drugs. | Different: our device<br>is specified as blue,<br>not lavender blue. Our<br>device does not<br>include polymer<br>coating | |
| Device Classification Name/<br>Regulation number | Patient Examination Glove<br>21 CFR Part 880.6250 | Patient Examination Glove<br>21 CFR Part 880.6250 | Same | |
| Product Code | LZA, LZC | LZA, LZC | Same | |
| Intended Use | This device is an ambidextrous patient<br>examination glove that is a non-sterile,<br>single use, disposable device intended for<br>medical purposes, worn on the examiner's<br>hand or finger to prevent contamination<br>between patient and examiner. The tested<br>chemotherapy drugs are:<br>Carmustine (BCNU) (3.3 mg/ml).<br>Permeation time: Carmustine (BCNU) has<br>extremely low permeation times of 14.7<br>minutes.<br>Cisplatin (1.0 mg/ml). Permeation time: no<br>breakthrough up to 240 minutes<br>Cyclophosphamide (Cytoxan) (20.0<br>mg/ml). Permeation time: no<br>breakthrough up to 240 minutes<br>Cytarabine (100 mg/ml). Permeation time:<br>no breakthrough up to 240 minutes<br>Dacarbazine (DTIC) (10.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Doxorubicin Hydrochloride (2.0 mg/ml).<br>Permeation time: no breakthrough up to<br>240 minutes<br>Etoposide (20.0 mg/ml). Permeation time:<br>no breakthrough up to 240 minutes<br>Fluorouracil (50.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Ifosfamide (50.0 mg/ml). Permeation time:<br>no breakthrough up to 240 minutes<br>Methotrexate (25.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Mitomycin C (0.5 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Mitoxantrone (2.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Paclitaxel (Taxol) (6.0 mg/ml). Permeation<br>time: no breakthrough up to 240 minutes<br>Thiotepa (10.0 mg/ml). Permeation time:<br>Thiotepa has extremely low permeation<br>times of 13.6 minutes<br>Vincristine Sulfate (1.0 mg/ml).<br>Permeation time: no Breakthrough up to<br>240 minutes. | Identical, except that the following drugs were not<br>tested: Carmustine (BCNU), Cytarabine, Ifosfamide,<br>Mitomycin C, Mitoxantrone and Thiotepa.<br><br>Name<br>Carmustine<br>(BCNU) (3.3<br>mg/ml)<br>Cisplatin (1.0<br>mg/ml)<br>Cyclophosphamide (Cytoxan) (20.0<br>mg/ml)<br>Cytarabine (100<br>mg/ml)<br>Dacarbazine<br>(DTIC) (10.0<br>mg/ml)<br>Doxorubicin<br>Hydrochloride<br>(2.0 mg/ml)<br>Etoposide (20.0<br>mg/ml)<br>Fluorouracil (50.0<br>mg/ml)<br>Ifosfamide (50.0<br>mg/ml)<br>Methotrexate<br>(25.0 mg/ml)<br>Mitomycin C (0.5<br>mg/ml)<br>Mitoxantrone<br>(2.0 mg/ml)<br>Paclitaxel (Taxol)<br>(6.0 mg/ml)<br>Thiotepa (10.0<br>mg/ml)<br>Vincristine Sulfate<br>(1.0 mg/ml) | Break through times<br>Not tested<br>no breakthrough up to<br>240 minutes<br>no breakthrough up to<br>240 minutes<br>Not tested<br>no breakthrough up to<br>240 minutes<br>no breakthrough up to<br>240 minutes<br>no breakthrough up to<br>240 minutes<br>no breakthrough up to<br>240 minutes<br>Not tested<br>no breakthrough up to<br>240 minutes<br>no breakthrough up to<br>240 minutes<br>Not tested<br>no breakthrough up to<br>240 minutes<br>Not tested<br>no breakthrough up to<br>240 minutes | Similar |

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| Materials | Nitrile | Nitrile | Identical |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Color | Blue | Lavender Blue | Different |
| Standards used | ISO 10993-10<br>ASTM D6319-10<br>ASTM D6124-06<br>ASTM D5151-06<br>ASTM D6978-05<br>ISO 2859-1<br>ASTM D412-16<br>ASTM D3767-03<br>ASTM D573-04 | Same | Same |
| Non-Sterile, Single Use,<br>disposable | Yes | Yes | Same |
| Packaging | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Same |
| Labeling Features | Non-Sterile<br>Powder Free<br>Examination Gloves<br>Ambidextrous, by Size<br>Single use only<br>Device Color<br>Manufactured for:<br>Lot Number:<br>Quantity by Weight<br>Made in Malaysia | Non-Sterile<br>Powder Free<br>Examination Gloves<br>Ambidextrous, by Size<br>Single use only<br>Device Color<br>Manufactured for:<br>Lot Number:<br>Quantity by Weight<br>Made 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 contact<br>sensitizer under conditions of the study | Not a primary irritant and not a contact sensitizer<br>under 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.