BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

K162186 · Brightway Holdings Sdn. Bhd. · LZC · Mar 31, 2017 · General Hospital

Device Facts

• Record ID: K162186
• Device Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM
• Applicant: Brightway Holdings Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: Mar 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; provides barrier protection for examiner and patient. Manufactured from nitrile compound; powder-free; sterling or grey color. Tested for resistance to chemotherapy drug permeation per ASTM D6978. Used in clinical settings by healthcare professionals. Output is physical barrier protection. Benefits include reduced risk of cross-contamination and protection against specific chemotherapy agents during handling. Warning: Do not use with Carmustine or Thiotepa due to low permeation times.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via ASTM D6319-10 (physical properties, pinhole, dimensions), ASTM D6978-05 (chemotherapy permeation), and ISO 10993-10/11 (biocompatibility: non-sensitizing, non-irritating, non-systemically toxic).

Technological Characteristics

Nitrile compound; powder-free; 12-inch length. Complies with ASTM D6319-10 (tensile strength >14 MPa, elongation >500%, thickness >0.05mm). Biocompatibility per ISO 10993-10 and 10993-11. Chemotherapy resistance per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable patient examination glove to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs per ASTM D6978. Contraindicated for use with Carmustine and 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

• Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim (K081089)

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

March 31, 2017

Brightway Holdings Sdn Bhd G. Baskaran Group Managing Director Lot 1559, Jalan Istimewa, Batu Belah Klang, Selangor Darul Ehsan 42100 MY

Re: K162186

Trade/Device Name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12" POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: February 8, 2017 Received: February 23, 2017

Dear G. Baskaran:

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 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

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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 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 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 Tina Kiang, Ph.D. 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) K162186

#### Device Name

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

#### Indications for Use (Describe)

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows:

| Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time |
|---------------------------------------------------|-------------------------------------|
| • Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 4.3 Minutes |
| • Cisplatin (1.0mg/ml), (1,000 ppm) | >240 Minutes |
| • Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm) | >240 Minutes |
| • Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) | >240 Minutes |
| • Doxorubicin HCL(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Etoposide /Toposar (20mg/ml), (20,000 ppm) | >240 Minutes |
| • Fluorouracil(50mg/ml), (50,000 ppm) | >240 Minutes |
| • Ifosfamide (50mg/ml), (50,000 ppm) | >240 Minutes |
| • Mitoxantrone(2mg/ml),(2,000 ppm) | >240 Minutes |
| • Paclitaxel(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| • Thiotepa (10mg/ml),(10,000 ppm) | 10.9 Minutes |
| • Vincristine Sulfate (1.0mg/ml),(1,000 ppm) | >240 Minutes |

Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes, respectively.

Warning: Do not use with Carmustine and Thiotepa.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(K) SUMMARY

#### BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

- 1. Submitter :

| Company Name : | BRIGHTWAY HOLDINGS SDN. BHD. |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Street Address : | Lot 1559, Jalan Istimewa,<br>Batu Belah, 42100 Klang<br>Selangor Darul Ehsan. |
| Country : | Malaysia |
| Phone No. : | 603-3343 1007 & 603-3343 1094. |
| Fax No. : | 603-3341 4800 |
| E-mail Address : | [e-mail] |
| Contact Person : | Mr. G. Baskaran (Group Managing Director)<br>[e-mail]<br>Mr. Felix Darrel (Group Marketing Manager)<br>[e-mail] |

- 2. Preparation Date : 13th March 2017
- 3. Name of the Device :

#### Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12″, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM

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Device Classification Name: Polymer Patient Examination Glove

#### (21 CFR 880.6250)

## Device common or usual name : NITRILE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS

FDA Device Class : Class 1

Product Code : LZC , LZA

#### 4. Identification of the Device :

Class I patient Examination glove tested for use with Chemotherapy Drugs, Powder Free, LZA and LZC, which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.

Predicate Device:

Legally Marketed Devices to which Substantial Equivalence is claimed:

K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

- 5. Device Description :
The subject device in this 510(k) Notification is Sterling/Grey coloured Nitrile Examination gloves, with claims and tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from nitrile compound, Sterling or Grey in colour, powder free and non sterile (as per 21 CFR 880.6250, class I).

The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

This device also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy drugs as per ASTM D6978-05

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#### 6. Intended use of the Device

BRIGHTWAY BRAND NITRILE EXAMINATION -GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The product has been tested with chemotherapy drugs in accordance with ASTM D6978. The breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration Minimum Breakthrough Detection Time Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) ● 4.3 Minutes >240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

10.9 Minutes

>240 Minutes

- Cisplatin(1.0mg/ml), (1,000 ppm)
- Cyclophosphamide/Cytoxan(20mg/ml), (20,000 ppm)
- Dacarbazine(DTIC) 10mg/ml, (10,000 ppm) ●
- Doxorubicin HCL(2mg/ml),(2,000 ppm)
- Etoposide /Toposar (20mg/ml), (20,000 ppm)
- Fluorouracil(50mg/ml), (50,000 ppm)
- Ifosfamide (50mg/ml), (50,000 ppm)
- Mitoxantrone(2mg/ml),(2,000 ppm)
- Paclitaxel(6.0mg/ml),(6,000 ppm)
- Thiotepa (10mg/ml),(10,000 ppm)
- . Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that Carmustine and Thiotepa have extremely low permeation times of 4.3 minutes and 10.9 minutes, respectively.

#### Warning: Do not use with Carmustine and Thiotepa.

#### 7. Substantial Equivalence Based on Assessment of Non-Clinical Performance Data

Testing was performed per ASTM D6319-10 , ASTM D5151-06, ASTM D6124- 06,ISO 10993-10:2010 and 16 CFR Part 1500.41. The glove meet standards requirement referenced in section 6.0 above.

Biocompatibility tests indicated that under the conditions of the studies, the gloves were nonsensitizing, non-irritating, and non-systemically toxic

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- 8. Summary of Technical Characteristics and Substantial Equivalence Compared to Predicate Device
The predicate device in scope is as follows

1. K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

The subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is substantially equivalent in safety and effectiveness to K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

The subject device and predicate device use a similar Nitrile barrier film to achieve a device for the intended use. The properties between the subject device and the predicate device are compared in the following table:

| | | Device Performance | | |
|------------------|----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Characteristics | Standard | Predicate Device :<br>K 081089 - Kimberly-<br>Clark STERLING*<br>Nitrile & STERLING*<br>NITRILE-EXTRA<br>Powder-Free Exam<br>Gloves with<br>Chemotherapy Drug<br>Use Claim | Subject Device :<br>BRIGHTWAY<br>BRAND NITRILE<br>EXAMINATION<br>GLOVES 12",<br>POWDER FREE,<br>[STERLING/GREY]<br>WITH<br>CHEMOTHERAPY<br>CLAIM | Result of<br>Comparison |
| Labeling | N/A | There are no special<br>labeling claims and<br>do not claim gloves<br>as hypoallergenic on<br>labels. | There are no<br>special labeling<br>claims and do not<br>claim gloves as<br>hypoallergenic on<br>labels. | Same |
| Device Materials | N/A | Nitrile Compound | Nitrile Compound | Same |
| Colour | N/A | Sterling | Sterling / Grey | Same |

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| Device Tolerances and Specifications & Performance Data | | | | |
|---------------------------------------------------------|--------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------|------|
| | | | | |
| Tensile strength :<br>Before and after<br>ageing | ASTM<br>6319-10 | > 14 Mpa | > 14 Mpa | Same |
| Ultimate Elongation :<br>Before and after<br>ageing | ASTM<br>6319-10 | > 500 % | > 500 % | Same |
| Freedom from<br>Pinholes : | ASTM 6319-10<br>(FDA 1000 ml water<br>leak test) | Pass | Pass | Same |
| Dimensions:<br>Length | ASTM<br>6319-10 | > 295 mm | > 295 mm<br>(295 mm minimum<br>-325 mm) | Same |
| Width | ASTM<br>6319-10 | 70±10 mm to<br>120±10 mm (sizes XS<br>to XL) | 70±10 mm to<br>120±10 mm (sizes XS<br>to XL) | Same |
| Thickness | ASTM<br>6319-10 | > 0.05 mm (palm &<br>finger) | > 0.05 mm<br>(Palm :0.075mm-<br>0.08mm<br>Finger : 0.085mm-<br>0.10mm) | Same |
| Residual Powder : | ASTM<br>6319-10, | Less than 2 mg per<br>glove ; PASS | Less than 2 mg per<br>glove ; PASS | Same |
| Biocompatibility | | | | |
| Primary Skin<br>Irritation test | ISO 10993-<br>10 | Under conditions of<br>the study, not an<br>irritant | Under conditions of<br>the study, not an<br>irritant | Same |
| Dermal sensitization<br>assay | ISO 10993-<br>10 | Under conditions of<br>the study, not a<br>sensitizer | Under conditions of<br>the study, not a<br>sensitizer | Same |
| Systemic Toxicity | ISO 10993-<br>11 | Pass | Pass | Same |

-

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| Chemical Permeation / Chemotherapy Testing | | | | |
|--------------------------------------------|----------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------|
| Resistance to | ASTM | Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times of | Carmustine and<br>Thiotepa have<br>extremely low<br>permeation times<br>of less than 30 | |
| Permeation | D6978-05 | less than 30 minutes | minutes | Same |

#### 9. Conclusion

Based on intended use, technological characteristics and Non-Clinical performance data, the subject device; BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12", POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPY CLAIM is substantially equivalent to the predicate device K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim.

Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K081089 - Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-EXTRA Powder-Free Exam Gloves with Chemotherapy Drug Use Claim.

The subject device meets the requirements of ASTM D 6319- 10 standards as well as applicable 21 CFR references, and meets FDA recognized standards for physical properties requirements, pinhole requirements, biocompatibility requirements which are as shown and discussed above.

Based on the complete list of non-clinical tests, the subject device herein mentioned, is as safe, as effective, and performs as well as the legally marketed predicate devices.