Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs

K161215 · Brightway Holdings Sdn. Bhd. · LZA · Dec 21, 2016 · General Hospital

Device Facts

• Record ID: K161215
• Device Name: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
• Applicant: Brightway Holdings Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Dec 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Story

Disposable nitrile examination glove; sterling/grey color; powder-free; non-sterile. Provides single-use barrier protection for clinician hands during patient examinations. Tested for permeation resistance against 12 specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings by healthcare professionals. Output is physical barrier protection; prevents cross-contamination between patient and examiner. Benefits include reduced exposure to biological contaminants and specific hazardous chemotherapy agents.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via ASTM D6319-10 (physical properties), ASTM D5151-06 (pinhole testing, AQL 1.0), ASTM D6124-06 (powder residue), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing per ISO 10993-10 (sensitization, irritation) and ISO 10993-11 (systemic toxicity) confirmed the device is non-sensitizing, non-irritating, and non-systemically toxic.

Technological Characteristics

Nitrile compound; powder-free; sterling/grey color; ambidextrous. Dimensions and physical properties comply with ASTM D6319-10. Barrier integrity tested per ASTM D5151-06 (G2 AQL 1.0). Biocompatibility per ISO 10993. Manufactured in ISO 9001:2008 and ISO 13485:2003/EN ISO 13485:2012 certified facilities.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs.

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

• Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile (K151750)

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

December 21, 2016

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

Re: K161215

Trade/Device Name: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] 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: November 16, 2016 Received: November 21, 2016

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

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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 yours,

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161215

Device Name

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS

#### Indications for Use (Describe)

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiners hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

Test Chemotherapy Drug Name and Concentration

- · Carmustine (BCNU) (3.3mg/ml),(3.300 ppm)
- · 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/Taxol(6.0mg/ml),(6.000 ppm)
- · Thiotepa (10mg/ml),(10,000 ppm)
- · Vincristine Sulfate(1.0mg/ml),(1,000 ppm)

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.

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)

Minimum Breakthrough Detection Time

5.4 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

>240 Minutes

40.4 Minutes

>240 Minutes

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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# 510(K) SUMMARY

# K161215

## BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS

- 1. Submitter :

| Company Name : | BRIGHTWAY HOLDINGS SDN. BHD. |
|------------------|--------------------------------------------|
| Street Address: | Lot 1559, Jalan Istimewa, |
| | Batu Belah, 42100 Klang |
| | 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) |
| | [e-mail] |
| | Mr. Felix Darrel (Group Marketing Manager) |
| | [e-mail] |

- 30th November 2016 2. Preparation Date :
- 3. Name of the Device :

### Device trade or proprietary name: BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS

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# Device Classification Name: Polymer Patient Examination Glove (21 CFR 88.6250)

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

FDA Device Class: Class 1

Product Code: LZA, LZC

### 4. Identification of the Device :

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

### 5. Device Description:

The subject device in this 510(k) Notification is a Sterling/Grey 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 Grev in color, 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 is manufactured in facilities compliant to ISO 9001:2008 certified in Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath

The device is manufactured to comply with ISO 13485:2003 / EN ISO 13485:2012 Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination & Sterile Surgical Gloves

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### 6. Intended use of the Device

BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] TESTED FOR USE WITH CHEMOTHERAPHY DRUGS is a disposable device intended for medical purpose worn on the examiner's hand or finger to prevent contamination between patient and examiner.

The tested chemotherapy drugs and their breakthrough detection times are as follows:

| Test Chemotherapy Drug Name and Concentration | Minimum Breakthrough Detection Time |
|---------------------------------------------------|-------------------------------------|
| • Carmustine (BCNU) (3.3mg/ml),(3,300 ppm) | 5.4 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/Taxol(6.0mg/ml),(6,000 ppm) | >240 Minutes |
| • Thiotepa (10mg/ml),(10,000 ppm) | 40.4 Minutes |
| • Vincristine Sulfate(1.0mg/ml),(1,000 ppm) | >240 Minutes |

Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 5.4 minutes and Thiotepa 40.4 minutes.

### 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.

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. Legally Marketed Device to which Substantial Equivalence is Claimed

The legally marketed predicate device in scope is as follows:

- 1) K151750 Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile
### Substantial Equivalence Comparison Table:

The subject Device, K161215 - BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [STERLING/GREY] WITH CHEMOTHERAPHY CLAIM is substantially equivalent in safety and effectiveness to K151750 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

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:

| Characteristics | Subject Device<br>K161215 | Predicate Device<br>K151750 | Comments |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sterling/Grey | Blue, White | |
| Manufacturer | Brightway Holdings Sdn Bhd | Kossan International Sdn Bhd | N/A |
| 510(K) Number | K161215 | K151750 | N/A |
| Identification | Nitrile Examination Gloves, Powder Free,Sterling/Grey Coloured, Tested For Use with Chemotherapy Drugs | 1. Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs<br>2. Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs | N/A |
| 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 |
| | BRIGHTWAY BRAND<br>NITRILE EXAMINATION<br>GLOVES, POWDER FREE,<br>[STERLING/GREY] TESTED<br>FOR USE WITH<br>CHEMOTHERAPHY<br>DRUGS is a disposable<br>device intended for<br>medical purpose worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner. | A patient examination<br>glove is a disposable<br>device intended for<br>medical purposes that is<br>worn on the examiner's<br>hand to prevent<br>contamination between<br>patient and examiner.<br>These gloves were<br>tested for use with<br>chemotherapy drugs<br>per ASTM D6978-05<br>(Reapproved 2013)<br>Standard Practice for<br>Assessment of Medical<br>Gloves to Permeation<br>by Chemotherapy Drugs | |
| Intended Use | | Same | Same |
| Materials | Nitrile | Nitrile | Same |
| Color | Grey / Sterling | Blue, and White | The difference in<br>color does<br>not raise any<br>safety issues |
| Design | Meet Requirements of<br>ASTM D6319 | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large<br>Double Extra Large | Same |
| Single Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Length | minimum 230 mm,<br>target 242 mm,<br>maximum 258 mm,<br>Meets Requirements of<br>ASTM D6319 | min 230 mm / ≥<br>230mm, Meets<br>Requirements of ASTM<br>D6319 | Same |
| Thickness(mm) | | | Meets<br>requirements of<br>ASTM D6319<br>Subject Device |
| Cuff | 0.05-0.07 | 0.032-0.050 | |
| Palm | 0.06-0.09 | 0.055-0.085 | Meets<br>requirements of<br>ASTM D6319 |
| Finger | 0.07-0.10 | 0.065-0.095 | Meets<br>requirements of<br>ASTM D6319 |
| Powder Free Residue | ≤ 2mg/glove | ≤ 2mg/glove | Same |
| Physical Properties | Meets Requirements of<br>ASTM D6319 | Meets Requirements of<br>ASTM D6319 | Same |
| Freedom from pinholes<br>testing | Tested in accordance<br>with ASTM D5151 test<br>method. Pass quality level<br>at G2 AQL 1.0 | Tested in accordance<br>with ASTM D5151 test<br>method. Pass quality<br>level at G1 AQL 1.5 | Tested to Same<br>standard. Subject<br>device tested to a<br>more stringent<br>criteria of G2 AQL<br>1.0 |
| Biocompatibility Test | | | |
| Dermal Sensitization (as<br>ISO 10993- 10:2010) | Not a contact sensitizer<br>under the<br>conditions of the study | Not a contact sensitizer<br>under the<br>conditions of the study | Same |
| Primary Skin Irritation<br>Test (as ISO 10993-<br>10:2010) | Not a primary skin irritant<br>under the<br>conditions of the study | Not a primary skin<br>irritant under<br>the conditions of the<br>study | Same |
| | | | |
| Systemic Toxicity (ISO<br>10993-11) | Under the conditions of<br>the study, no mortality or<br>no evidence of Systemic<br>Toxicity was observed | N/A | Predicate device<br>was not tested<br>for Systemic<br>Toxicity, Subject<br>device was tested<br>for Acute<br>Systemic Toxicity<br>and no mortality<br>or evidence of<br>Systemic Toxicity<br>was observed |
| Labelling Features | - Non-sterile<br>- Powder Free<br>- Examination Gloves<br>- Ambidextrous, by Size<br>- Single Use Only<br>- Device Color<br>- Manufactured Date :<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 Malaysia | Same |
| Chemotherapy Drugs<br>Permeation Test | | | |
| Chemotherapy Drugs<br>(Concentrations) | Minimum Breakthrough<br>Detection Time in<br>Minutes | Minimum Breakthrough<br>Detection Time in<br>Minutes | |
| • Carmustine (BCNU)<br>(3.3mg/ml),(3,300 ppm) | 5.4 | 10.1 | Below 30 minutes<br>permeation time,<br>same as the<br>predicate device |
| • Cisplatin (1.0mg/ml),<br>(1,000 ppm) | >240 | >240 | Same |
| •<br>Cyclophosphamide/Cytox<br>an(20mg/ml), (20,000<br>ppm) | >240 | >240 | Same |
| • Dacarbazine(DTIC)<br>10mg/ml, (10,000 ppm) | >240 | >240 | Same |
| • Doxorubicin<br>HCL(2mg/ml),(2,000 ppm) | >240 | >240 | Same |
| • Fluorouracil(50mg/ml),<br>(50,000 ppm) | >240 | >240 | Same |
| • Ifosfamide (50mg/ml),<br>(50,000 ppm) | >240 | >240 | Same |
| • Mitoxantrone(2mg/ml),(2<br>,000 ppm | >240 | >240 | Same |
| • Paclitaxel/Taxol(6.0mg/m<br>I),(6,000 ppm) | >240 | >240 | Same |
| • Thiotepa<br>(10mg/ml),(10,000 ppm) | 40.4 | 30.2(Blue) and<br>10.4(White) | Predicate device<br>(Blue) at 30.2<br>minutes;<br>and (White)<br>below 30 minutes<br><br>Subject Device<br>had a permeation<br>time of 40.4 mins<br>which exceeded<br>30 mins. less than<br>60 mins. |
| • Vincristine<br>Sulfate(1.0mg/ml),(1,000<br>ppm) | >240 | >240 | Same |
| Warning Statement | WARNING: Not for use<br>with Carmustine,<br>ThioTEPA | WARNING:<br>Do Not Use with<br>Carmustine and<br>Thiotepa | Same |
| Labelling Claim | Tested for Use with<br>Chemotherapy Drugs | Tested for Use with<br>Chemotherapy Drugs | Same |

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30th November 2016

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### 11.0 Conclusion

Based on intended uses, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the predicate device K151750 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile

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

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