Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs

K152542 · Riverstone Resources Sdn Bhd · LZA · Dec 24, 2015 · General Hospital

Device Facts

• Record ID: K152542
• Device Name: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs
• Applicant: Riverstone Resources Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Dec 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A powder-free 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 .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.

Device Story

Disposable blue nitrile examination glove; non-sterile; powder-free. Worn by healthcare examiners to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05. Used in clinical settings; over-the-counter availability. Provides barrier protection; low dermatitis potential claim based on absence of specific chemical additives (thiuram, carbamate, thiazole).

Clinical Evidence

Modified Draize-95 sensitization study conducted on 205 non-sensitized adult human subjects. Study evaluated potential for dermal irritation and sensitization. Results showed no clinical evidence of residual chemical additives capable of inducing Type IV allergy. All results negative; device classified as non-irritant and non-sensitizer.

Technological Characteristics

Nitrile compound; blue color; powder-free; non-sterile. Dimensions: 270mm length, 0.10mm palm/finger thickness. Meets ASTM D6319-10 (physical properties), ASTM D5151-06 (pinholes), and ASTM D6124-06 (residual powder). Biocompatibility per ISO 10993-10:2010. Chemotherapy resistance per ASTM D6978-05.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands or fingers to prevent contamination between patient and examiner. Suitable for use with chemotherapy drugs as specified in the permeation testing data.

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 Examination (Blue) (K050122)
• EMG Blue Nitrile examination Gloves Powder Free with tested for use with Chemotherapy Drugs (K141623)

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 24, 2015

Riverstone Resources Sdn. Bhd. Mr. Suresh Kumar Quality Assurance Manager Lot 55 & 56, No 13, Jalan Jasmin 2 Kawasan Perindustrian Bukit Beruntung Selangor 48300 MALAYSIA

Re: K152542

Trade/Device Name: Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: Undated Received: November 30, 2015

## Dear Mr. Kumar:

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.

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 and Part 809), 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 yours.

*Tejashri Purohit-Sheth, M.D.*

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

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

## 510(k) Number (if known) K152542

### Device Name

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs

### Indications for Use (Describe)

The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.

Minimum Breakthrough Detection time in minutes, 0.01ug/cm2/minute Chemotherapy Drugs and Concentration

20.1 Minutes

> 240 Minutes > 240 Minutes

> 240 Minutes

> 240 Minutes

> 240 Minutes > 240 Minutes

> 240 Minutes

50.6 minutes

- 1)Carmustine (BCNU)(3.3mg/ml) 2)Cyclophosphamide (20mg/ml) 3)Cisplatin (1.0mg/ml)(1000ppm) 4)Doxorubicin Hydrochloride (2 mg/ml) 5) Etoposide (20mg/ml) 6) Fuorouracil (50mg/ml) 7)Methorexate (25mg/ml) 8)Paclitaxel (6mg/ml) 9)Thiotepa (10mg/ml)
The Maximum testing time is 240 minutes . Please note that the following drugs have low permeation time 1) Carmustine (BCNU)(3.3mg/ml) with Permeation time of 20.1 minutes 2) Thiotepa (10mg/ml) with Permeation time of 50.6 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)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY -------

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(K) Summary Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with Tested for use with Chemotherapy Drugs

# 1.0 Submitter :

| Company Name | : Riverstone Resources Sdn Bhd. |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| Company Address | : Lot 55 & 56,No 13, Jalan Jasmin 2<br>Kawasan Perindustrian Bukit Beruntung<br>48300,Bukit Beruntung,<br>Selangor,Malaysia. |
| Contact Person | : Mr Suresh Kumar |
| Telephone No | : 603-60283033 |
| Email | : [e-mail] |

# 2.0 Preparation Date : 14th December 2015

# 3.0 Name of the Device

Trade Name / Proprietary Name : Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy drugs.

Device Name : Nitrile Patient Examination gloves.

Device Classification Name : Patient Examination gloves (21 CFR 880.6250).

Device Class : Class I.

Product Code :LZA , LZC.

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#### 4.0) Identification of The Legally Marketed Device :

Class I patient Examination glove with claiming, this product contain Low Dermatitis Potential Claim 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.

Predicate Device: K050122. Powder Free Nitrile Examination (Blue) (This Product does not contain Thiuram and/or Carbamate and/or Thiazole) and K141623.EMG Blue Nitrile examination Gloves Powder Free with tested for use with Chemotherapy Drugs labeling claim

#### 5.0 Device Description

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

# 6.0 Intended use of the Device

A powder-free 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 .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.

# 6.0 Specification for Nitrile gloves: 6.1 Dimension and Thickness of Gloves

| Dimension | Size S | Size M | Size L | Size XL |
|------------------------------|---------|---------|---------|---------|
| Overall Length (mm) | 270min | 270min | 270min | 270min |
| Width (± 5mm) | 85 | 95 | 105 | 115 |
| Thickness at Palm (mm) | 0.10min | 0.10min | 0.10min | 0.10min |
| Thickness at Finger Tip (mm) | 0.10min | 0.10min | 0.10min | 0.10min |

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# 6.1.2 Gloves Physical Properties and Holes

| Measurement | Before Ageing | After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs |
|-------------------------|---------------------------------|-------------------------------------------------------|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Inspection Level G-1 |

Gloves meet all the specification listed in ASTM D 6319-10

| Characteristi<br>ભ્યું હિંદ્ર | Acceptance<br>Criteria | Powder Free<br>Nitrile Examination<br>Gloves(Blue) with<br>Low Dermatitis<br>Potential Claim and<br>with tested for use<br>with chemotherapy<br>drugs,K152542 | Powder Free<br>Nitrile<br>Examination<br>Gloves (This<br>Product does not<br>contain Thiuram<br>and/or Carbamate<br>and/or Thiazole)<br>,K050122 | EMG Blue Nitrile<br>Examination glove<br>Powder free with tested<br>for use with<br>Chemotherapy Drugs<br>labeling Claim,K141623 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LZA, LZC | LZA, LZC | LZA | LZA ,LZC |
| Intended use | A powder free<br>patient<br>examination<br>glove is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on<br>the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>The device is for<br>over-the-counter<br>use. | A powder free patient<br>examination glove is<br>a disposable device<br>intended for medical<br>purposes that is worn<br>on the examiner's<br>hand or finger to<br>prevent<br>contamination<br>between patient and<br>examiner. The device<br>is for over-the-<br>counter use. | A powder free<br>patient examination<br>glove is a<br>disposable device<br>intended for<br>medical purposes<br>that is worn on the<br>examiner's hand or<br>finger to prevent<br>contamination<br>between patient and<br>examiner. The<br>device is for over-<br>the-counter use. | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use. |
| Material use | Nitrile | Nitrile | Nitrile | Nitrile |
| | compound | compound | compound | compound |
| Colour | Blue | Blue | Blue | Blue |
| Sterility<br>Single used | Non sterile | Non sterile | Non sterile<br>Single used | Non sterile<br>Single used |
| | Single used | Single used | | |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile | Non Sterile |

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| Dimensions | Overall Length<br>(mm)<br>Min 270mm<br>Width (±5mm)<br>Size S =<br><b>85mm</b><br>Size M =<br><b>95mm</b><br>Size L =<br><b>105mm</b><br>Size XL =<br><b>115mm</b><br>Thickness at Palm<br>(mm)<br>Min; 0.10 mm<br>Thickness at<br>Finger Tip (mm)<br>Min 0.10 mm | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Appendix 2<br>Meets ASTM D6319-10 | Biological Evaluation on Medical Device --Primary Skin Irritation Test | | | Appendix 2 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | Biological Evaluation on Medical Device -Primary Skin Irritation Test | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | Under the conditions of this study, the test article was a non-irritant. | | | | |
| Physical properties | Before Ageing<br>Tensile Strength<br>(MPa)<br>= 14min<br>Ultimate<br>Elongation (%)<br>= 500min<br>After Aging at<br>70°C for<br>168 hrs @ 100°C<br>for 22 hrs<br>Tensile Strength<br>(MPa)<br>= 14min<br>Ultimate<br>Elongation (%)<br>= 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 | Biological Evaluation on Medical Device -Dermal Sensitization Assay | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. | Under the conditions of this study, the test article was a non-sensitizer. |
| | Resistance against Chemotherapy Drugs | 1) Carmustine (3.3mg/ml or 3000ppm), Breakthrough : 20.1 min.<br>2) Cyclophosphamide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.<br>3) Cisplatin (1mg/ml or 1000ppm), Breakthrough time : > 240 min<br>4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Breakthrough time : >240 min.<br>5) Etoposide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.<br>6) Flourouracil (50mg/ml or 50,000), Breakthrough time : >240 min.<br>7) Methotrexate (25mg/ml or 25,000ppm), Breakthrough time : > 240 min | | 1) Carmustine (3.3mg/ml or 3000ppm), Breakthrough: 4.5min.<br>2) Cyclophosphamide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.<br>3) Cytarabine (100mg/ml or 100,000ppm), Breakthrough time : >240 min<br>4)Doxorubicin Hydrochloride (2.0mg/ml or 2000ppm), Breakthrough time : >240 min.<br>5) Etoposide (20mg/ml or 20,000ppm), Breakthrough time : >240 min.<br>6) Flourouracil (50mg/ml or 50,000), Breakthrough time: >240 min.<br>7) Methotrexate (25mg/ml or 25,000ppm), Breakthrough time : > 240 min. | | | | |
| Freedom from<br>pinholes | AQL 2.5<br>Inspection Level<br>G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | | | | |
| Residual Powder | < 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 | Meets ASTM D6124-06 | | | | |

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| | | | Appendix 2 |
|-----------------------------------|------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | | 8) Paclitaxel (6mg/ml<br>or 6,000ppm),<br>Breakthrough time :<br>>240 min. | 8) Paclitaxel (6mg/ml or<br>6,000ppm), Breakthrough<br>time : >240 min. |
| | | 9) Thiotepa (10mg/ml<br>or 10,000ppm),<br>Breakthrough time :<br>50.6 min. | 9) Thiotepa (10mg/ml or<br>10,000ppm),<br>Breakthrough time : 6.88<br>min. |
| Low Dermatitis<br>Potential Claim | 1)Modified<br>Draize 95 test | No Clinical evidence<br>presence of residual<br>chemical additives<br>that may induce Type<br>IV allergy in human<br>subject | No Clinical<br>evidence presence<br>of residual<br>chemical additives<br>that may induce<br>Type IV allergy in<br>human subject |

# Resistance against Chemotherapy Drugs

| Chemotherapy Drug and concentration | Minimum Breakthrough detection time in Minutes,0.01µg/cm²/minute |
|---------------------------------------|------------------------------------------------------------------|
| 1)Carmustine (BCNU) (3.3mg/ml) | 20.1 minutes |
| 2)Cyclophosphamide (20mg/ml) | > 240 minutes |
| 3)Cisplatin (1mg/ml) | > 240 minutes |
| 4)Doxorubicin Hydrochloride (2 mg/ml) | > 240 minutes |
| 5)Etoposide (20mg/ml) | > 240 minutes |
| 6)Fluorouracil (50mg/ml) | > 240 minutes |
| 7)Methorexate (25mg/ml) | > 240 minutes |
| 8) Paclitaxel (6mg/ml) | > 240 minutes |
| 9) Thiotepa (10mg/ml) | 50.6 minutes |

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time. Carmustine (BCNU) (3.3mg/ml) Thiotepa (10mg/ml)

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# 7.0) Substantial Equivalent 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 test indicates the gloves are not a contact skin sensitizer and not a primary skin irritant

# 8.0) Substantial Equivalent Based on Assessment of Clinical Performance Data

Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and tested for Use with Chemotherapy drugs were tested in accordance with Modified Draize -95 test , per FDA's guidance document "Guidance for Industry and FDA Reviewer/Staffs: Premarket Notification [510k] Submissions for testing for skin sensitization to chemical in natural Rubber Products".

The study was conducted in two stages. In the first, a population of 30 human subjects was tested to evaluate the product for the potential to cause irritation or sensitization. The second stage was initiated on a further number of subjects to a total of a minimum 205 individuals after the first stage has shown that the test product does not indicate a potential for inducing dermal irritation and does not shown sensitization capability

The study completed on 205 non sensitized adult human subjects, who reasonably reflect the general user population in the US, gave all negative results. There was no clinical evidence of the presence of residual chemical additives at the level that may induce type IV allergy in the un-sensitized general user population in the tested ariticle.

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# 9.0 Conclusion

Based on intended uses, technological characteristics and Non-Clinical performance data, Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis Potential Claim and with tested for Use with Chemotherapy drugs is substantially equivalent to the predicate device (K050122) and (K141623)