BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free

K213408 · Meditech Gloves Sdn Bhd · LZA · Apr 17, 2022 · General Hospital

Device Facts

• Record ID: K213408
• Device Name: BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free
• Applicant: Meditech Gloves Sdn Bhd
• Product Code: LZA · General Hospital
• Decision Date: Apr 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A 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. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; ambidextrous; blue color; finger-textured. Used by healthcare professionals in clinical settings to provide a barrier against contamination between patient and examiner. Tested for permeation resistance against various chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05. Output is a physical barrier; healthcare providers use the glove to protect themselves and patients during examinations and drug handling. Benefits include reduced risk of cross-contamination and protection against specific hazardous chemical exposures, excluding Carmustine and Thio Tepa.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (ASTM D412), dimensions (ASTM D3767), water tightness (ASTM D5151), residual powder (ASTM D6124), chemotherapy drug permeation (ASTM D6978), and biocompatibility (ISO 10993).

Technological Characteristics

Material: Nitrile synthetic rubber. Form: Ambidextrous, finger-textured, powder-free. Standards: ASTM D6319-19, ASTM D6978-05, ASTM D5151, ASTM D6124-06, ISO 10993. Dimensions: Length min 240mm; thickness 0.06-0.10mm. Non-sterile.

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with specific chemotherapy drugs and Fentanyl Citrate. Contraindicated for use with Carmustine (BCNU) and Thio Tepa.

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

• Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 17, 2022

Meditech Gloves SDN BHD Wan Hassan Assistant Manager- OA/RA PT 3345, Jalan Permata 1/3, Arab Malaysian Industrial Park Nilai, Negeri Sembilan 71800 Malaysia

Re: K213408

Trade/Device Name: Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: March 12, 2022 Received: March 22, 2022

Dear Wan Hassan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Bifeng Oian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K213408

### Device Name

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) tested for use with Chemotherapy Drugs and Fentanyl Citrate

### Indications for Use (Describe)

A 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.

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Azacitidine. 25mg/ml (25,000 ppm) >240mins Bleomycin Sulphate 15mg/ml (15,000 ppm)>240mins Carboplatin 10mg/ml (10,000 ppm) >240mins Carmustine (BCNU) 3.3mg/ml (3300 ppm) 22.5mins Cetuximab 2mg/ml (2000 ppm) >240mins Cisplatin 1mg/ml (1000 ppm) >240mins Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm)>240mins Dacarbazine 10mg/ml (10,000 ppm)>240mins Docetaxel 10mg/ml (10,000 ppm) >240mins Doxorubicin HCl 2mg/ml (2,000 ppm) >240mins Ellence (Epirubicin) 2mg/ml (2,000 ppm) >240mins Etoposide 20mg/ml (20,000 ppm) >240mins Fluorouracil 50mg/ml (50.000 ppm) >240mins Gemcitabine 38mg/ml (38,000 ppm) >240mins Ifosfamide 50mg/ml (50,000 ppm) >240mins Irinotecan 20mg/ml (20,000 ppm) >240mins Methotrexate 25mg/ml (25,000ppm) >240mins Mitomycin C 0.5mg/ml (500 ppm) >240mins Mitoxantrone 2mg/ml (2,000 ppm) >240mins Oxaliplatin 2mg/ml (2,000ppm) >240mins Paclitaxel 6mg/ml (6,000 ppm) >240mins Rituximab 10mg/ml (10,000 ppm) >240mins Thio Tepa 10 mg/ml (10,000 ppm) 36.1 mins Vincristine Sulfate 1mg/ml 1,000 ppm) >240mins Vinorelbine 10mg/ml (10,000 ppm) >240mins Tested for Fentanyl Citrate is as follows: Fentanyl Citrate 100mcg/2ml >>240mins

Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins

Warning: Do not use these gloves with Camustine or Thio Tepa.

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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)

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#### 1.0 Submitter:

| Name: | Dr Effendi Tenang |
|------------|---------------------------------------------------------------------------------------------------------------------------------|
| Address: | Meditech Gloves Sdn Bhd<br>PT3345, Jalan Permata 1/3, Arab Malaysian Industrial Park,<br>71800 Nilai, Negeri Sembilan, MALAYSIA |
| Phone No.: | [phone] |
| Fax No.: | [phone] |

Date of Summary Prepared: April 15, 2022

#### 2.0 Name of the device:

Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

Common Name: Examination Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA, LZC, QDO)

### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed:

Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate 510(k) K192954 : Class I Regulatory : LZA, LZC, QDO Product Code :

### 4.0 Description of The Device:

Powder Free Nitrile Patient Examination Glove, Non-Sterile (Blue) meet all the requirements of ASTM standard D6319-19 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber Inner surface of gloves undergoes surface treatment process to produce a latex. smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand.

#### 5.0 Intended Use of the Device:

A 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.

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Г

These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

T

| Chemotherapy Drug and Concentration | Minimum<br>Breakthrough<br>Detection Time<br>(Minutes) |
|-------------------------------------------------|--------------------------------------------------------|
| Azacitidine, 25mg/ml (25,000 ppm) | >240mins |
| Bleomycin Sulphate 15mg/ml (15,000 ppm) | >240mins |
| Carboplatin 10mg/ml (10,000 ppm) | >240mins |
| Carmustine (BCNU) 3.3mg/ml (3300 ppm) | 22.5mins |
| Cetuximab 2mg/ml (2000 ppm) | >240mins |
| Cisplatin 1mg/ml (1000 ppm) | >240mins |
| Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm) | >240mins |
| Dacarbazine 10mg/ml (10,000 ppm) | >240mins |
| Docetaxel 10mg/ml (10,000 ppm) | >240mins |
| Doxorubicin HCl 2mg/ml (2,000 ppm) | >240mins |
| Ellence (Epirubicin) 2mg/ml (2,000 ppm) | >240mins |
| Etoposide 20mg/ml (20,000 ppm) | >240mins |
| Fluorouracil 50mg/ml (50,000 ppm) | >240mins |
| Gemcitabine 38mg/ml (38,000 ppm) | >240mins |
| Ifosfamide 50mg/ml (50,000 ppm) | >240mins |
| Irinotecan 20mg/ml (20,000 ppm) | >240mins |
| Methotrexate 25mg/ml (25,000ppm) | >240mins |
| Mitomycin C 0.5mg/ml (500 ppm) | >240mins |
| Mitoxantrone 2mg/ml (2,000 ppm) | >240mins |
| Oxaliplatin 2mg/ml (2,000ppm) | >240mins |
| Paclitaxel 6mg/ml (6,000 ppm) | >240mins |
| Rituximab 10mg/ml (10,000 ppm) | >240mins |
| Thio Tepa 10 mg/ml (10,000 ppm) | 36.1 mins |
| Vincristine Sulfate 1mg/ml 1,000 ppm) | >240mins |
| Vinorelbine 10mg/ml (10,000 ppm) | >240mins |

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### Tested for Fentanyl Citrate is as follows:

Fentanyl Citrate 100mcg/2ml

>240mins

Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins

Warning: Do not use these gloves with Camustine or Thio Tepa.

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### 6.0 Comparison of the Technological Characteristics with the Predicate Device:

The Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards of the subject gloves to the predicate device

| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON ANALYSIS |
|--------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | | PREDICATE<br>BLUE | CURRRENT<br>BLUE | |
| 510(k) Number | - | K192954 | K213408 | |
| Manufacturer(s) | - | Comfort Rubber Gloves<br>Industries Sdn. Bhd. | Meditech Gloves Sdn Bhd | |
| Material | ASTM D6319-19 | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger textured | Finger textured | Same |
| Physical Properties | ASTM D6319-19 | Meets | Meets | Same |
| Thickness - Finger<br>- Palm | ASTM D6319-19 | Min 0.05mm<br>Min 0.05mm | 0.07- 0.10mm<br>0.06- 0.09mm | Similar |
| Width | ASTM D6319-19 | XS Not Provided<br>S Not Provided<br>M Not Provided<br>L Not Provided<br>XL Not Provided | XS 70-75mm<br>S 80-86mm<br>M 93-97mm<br>L 102-106mm<br>XL 114-116mm | Different |
| | XS 70±10mm<br>S 80±10mm<br>M 95±10mm<br>L 110±10mm<br>XL >110mm | | | |
| Length | ASTM D6319-19 | Min 240mm | Min 240mm | Same |
| Powder Free | ASTM D6124-06 | ≤ 2 mg/glove | ≤ 2 mg/glove | Same |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON<br>ANALYSIS |
| | | PREDICATE<br>BLUE | CURRRENT<br>BLUE | |
| Biocompatibility | Primary Skin Irritation -<br>ISO 10993-10:2010 | Passes<br>Under the conditions of the<br>stud, the subject device is non-<br>irritating | Passes (Not a primary skin<br>irritant)<br>There was no erythema or<br>oedema noted on test site<br>after (1±0.1), (24±2),<br>(48±2) and (72±2) hours.<br>The primary Irritation Index<br>(PII) was "0". Also, no<br>mortality after 72 hours. The<br>gloves considered<br>negligible. | Similar |
| Biocompatibility | Dermal Sensitization- ISO<br>10993-10:2010 | Passes<br>Under the conditions of the<br>stud, the subject device is non-<br>sensitizing | Passes (Not a contact<br>sensitizer)<br>There was no positive<br>allergic reaction observed<br>during the challenge phase<br>(at 0, 24 hours and 48<br>hours) in animals treated<br>with the test material and<br>negative control. | Similar |
| Biocompatibility | Cytotoxicity - MEM Elution,<br>ISO 10993-5:2009 | Exhibit severe cytotoxicity<br>reactivity at 100% and 66%<br>extract concentration and no<br>cytotoxicity at 44%, 30%, 20%<br>and 15% extract concentration<br>under the condition of this test. | Exhibit severe cytotoxicity<br>reactivity at 100%, 50%,<br>and 25% extract<br>concentration.<br>No cytotoxicity reactivity at<br>12.5%, 6.25% and 3.125%<br>extract concentrations. | Similar |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON<br>ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Biocompatibility | Acute Systemic Toxicity,<br>ISO 10993-11:2017 (E) | Passes<br>Under the conditions of the<br>study, the subject showed no<br>adverse biological reaction. | Passes (no adverse biological<br>reaction )<br>No mortality was observed<br>(72±2) hours | Same |
| Watertight (1000ml) | ASTM D6319-19 & ASTM<br>D5151 | Passes at AQL 1.5 | Passes at AQL 1.5 | Same |
| Indication for Use | | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hand<br>or finger to prevent<br>contamination between patient<br>and examiner. | A patient examination glove<br>is a disposable device<br>intended for medical purposes<br>that is worn on the<br>examiner's hand or finger to<br>prevent contamination<br>between patient and<br>examiner. | Same |
| | | These gloves were tested for<br>use with chemotherapy drugs<br>and Fentanyl Citrate per ASTM<br>D6978-05 (Reapproved 2019)<br>Standard Practice for<br>Assessment of Medical Gloves<br>to Permeation by<br>Chemotherapy Drugs. | These gloves were tested for<br>use with chemotherapy drugs<br>and Fentanyl Citrate per<br>ASTM D6978-05 (Reapproved<br>2019) Standard Practice for<br>Assessment of Medical Gloves<br>to Permeation by<br>Chemotherapy Drugs. | Same |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Chemotherapy Drugs Permeation Test ASTM D6978-05 (Reapproved 2019) | | | | |
| Chemotherapy Drug and<br>Concentration | ASTM D6978-05<br>(Reapproved 2019) | Minimum Breakthrough Detection Time (Minutes) | | |
| Azacitidine, 25mg/ml<br>(25,000 ppm) | | - | >240mins | Different |
| Bleomycin Sulphate<br>15mg/ml (15,000 ppm) | | - | >240mins | Different |
| Carboplatin 10mg/ml<br>(10,000 ppm) | | - | >240mins | Different |
| Carmustine (BCNU)<br>3.3mg/ml (3300 ppm) | | 18.32mins | 22.5mins | Similar |
| Cetuximab 2mg/ml (2000<br>ppm) | | - | >240mins | Different |
| Cisplatin 1mg/ml (1000<br>ppm) | | >240mins | >240mins | Same |
| Cyclophosphamide<br>(Cytoxan) 20mg/ml<br>(20,000 ppm) | | >240mins | >240mins | Same |
| Dacarbazine 10mg/ml<br>(10,000 ppm) | | >240mins | >240mins | Same |
| Docetaxel 10mg/ml (10,000<br>ppm) | | - | >240mins | Different |
| Doxorubicin HCl 2mg/ml<br>(2,000 ppm) | | >240mins | >240mins | Same |
| Ellence (Epirubicin) 2mg/ml<br>(2,000 ppm) | | - | >240mins | Different |
| Etoposide 20mg/ml (20,000<br>ppm) | | >240mins | >240mins | Same |
| | | | | |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON<br>ANALYSIS |
| | | PREDICATE<br>BLUE | CURRENT<br>BLUE | |
| Fluorouracil 50mg/ml<br>(50,000 ppm) | | >240mins | >240mins | Same |
| Gemcitabine 38mg/ml<br>(38,000 ppm) | | - | >240mins | Different |
| Ifosfamide 50mg/ml<br>(50,000 ppm) | | >240mins | >240mins | Same |
| Irinotecan 20mg/ml<br>(20,000 ppm) | | - | >240mins | Different |
| Methotrexate 25mg/ml<br>(25,000ppm) | | >240mins | >240mins | Same |
| Mitomycin C 0.5mg/ml (500<br>ppm) | | >240mins | >240mins | Same |
| Mitoxantrone 2mg/ml<br>(2,000 ppm) | | >240mins | >240mins | Same |
| Oxaliplatin 2mg/ml<br>(2,000ppm) | | - | >240mins | Different |
| Paclitaxel 6mg/ml (6,000<br>ppm) | | >240mins | >240mins | Same |
| Rituximab 10mg/ml<br>(10,000 ppm) | | - | >240mins | Different |
| <b>Thio Tepa 10 mg/ml</b><br>(10,000 ppm) | | 57.3mins | 36.1mins | Different |
| Vincristine Sulfate 1mg/ml<br>1,000 ppm) | | >240mins | >240mins | Same |
| Vinorelbine 10mg/ml<br>(10,000 ppm) | | - | >240mins | Different |
| Warning | | Do Not Use with Camustine | Do Not Use with Camustine or<br>Thio Tepa. | Different |
| Fentanyl Citrate<br>100mcg/2ml | | >240mins | >240mins | Same |
| | | | | |
| CHARACTERISTICS | STANDARDS | DEVICE COMPARISONS | | COMPARISON ANALYSIS |
| | | PREDICATE | CURRENT | |
| | | BLUE | BLUE | |
| Size | Medical Glove Guidance<br>Manual - Labeling | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Same |
| Single Use | Medical Glove Guidance<br>Manual – Labeling | Single use | Single use | Same |

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There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods.

However, the current glove is tested to many more chemotherapy drugs than the predicate and has passed the minimum penetration time of 240 minutes.

### 7.0 Summary of Non-Clinical Testing

The performance test data of the non-clinical tests for this powder free nitrile patient examination gloves is summarized as per below.

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| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | | Results | | Status | |
|------------------------|------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------|-------------|--------------|-------------|--------|------|
| | | | Before aging | After aging | Before aging | After aging | | |
| Physical<br>Properties | ASTM D412-16<br>(Standard Test Method<br>for Vulcanized Rubber<br>and Thermoplastic<br>Elastomers-Tension) | To evaluate the<br>tensile (tension)<br>properties of glove. | Tensile<br>Strength<br> | Min 14 MPa | Min 14 MPa | 14.4 | 16.3 | Pass |
| | | | Ultimate<br>Elongation | Min 500% | Min 400% | 506 | 402 | Pass |

| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|----------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Dimension | ASTM D3767-<br>03(2020) Standard<br>Practice for Rubber –<br>Measurement of<br>Dimensions | To measure the<br>length, width, and<br>thickness of glove | Length<br><br>Width:<br>XS<br>S<br>M<br>L<br>XL<br><br>Thickness | Min 240mm<br><br>Min 240<br>Ave = 72 mm<br>Ave = 83 mm<br>Ave = 95 mm<br>Ave = 104 mm<br>Ave = 115 mm<br><br>Thickness<br>Finger – 0.08mm<br>Palm – 0.05mm | Pass<br><br>Pass<br>Pass<br>Pass<br>Pass<br>Pass<br><br>Pass |
| | | | Min 240mm<br><br>70 ± 10 mm<br>80 ± 10 mm<br>95± 10 mm<br>110 ± 10 mm<br>>110<br><br>Finger – 0.05mm<br>Palm – 0.05mm | | |

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| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|----------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Water Tight | ASTM D 5151-19<br>Standard Test Method<br>for Detection of Holes<br>in Medical Gloves | To detect holes that<br>leak water and<br>thereby compromise<br>the usefulness of the<br>glove | Sample Size : 500<br>Inspection Level : GI<br>AQL : 1.5<br>Acceptance No : 14 | This batch sampling is 500,001<br>and over. Hence according to<br>single sampling plan GI, the<br>sample to be drawn is under Code<br>M equivalent to 500 pieces with<br>accept 14 and reject 15.<br>During the test, 12 pieces were<br>found with leaks. Hence it falls<br>within the acceptance criteria. | Pass |

| Test<br>Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Residual<br>Powder | ASTM D6124-06<br>(2017) Standard Test<br>Method for Residual<br>Powder on Medical<br>Gloves | To determine the<br>amount of residual<br>powder and non-<br>powder solids found<br>on gloves | Less than 2 mg per glove | Sample size : 5 pcs<br>Requirement : <2mg/glove<br>Result : 1.5 mg/glove | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
| Permeation by<br>Chemotherapy<br>Drugs | ASTM D6978-05<br>(2019) Standard<br>Practice for<br>Assessment of Medical<br>Gloves to Permeation<br>by Chemotherapy<br>Drugs | To determine the<br>minimum<br>breakthrough<br>Detection Time | ≥240mins | ≥240mins<br>Except for Camustine and<br>Thio Tepa | Pass |
| Test Method | Standard | Purpose of Testing | Acceptance Criteria | Results | Status |
| Biocompatibility<br>Primary Skin<br>Irritation | ISO 10993-<br>10:2010 | To demonstrates the<br>irritation potential of<br>the gloves, i.e., for<br>initiating or aggravating<br>damage through its<br>contact with the skin | Not a primary skin irritant<br>under the condition of this<br>test. | Not a primary skin irritant<br>There was no erythema or oedema<br>noted on test site after $(1\pm0.1)$ ,<br>$(24\pm2)$ , $(48\pm2)$ and $(72\pm2)$ hours.<br>The primary Irritation Index (PII)<br>was "0". Also, no mortality after 72<br>hours. The gloves considered<br>negligible. | Pass |
| Biocompatibility<br>Dermal<br>Sensitization | ISO 10993-<br>10:2010 | To demonstrate the<br>potential of the device<br>for eliciting a delayed<br>hypersensitivity (Type<br>IV) immunologic<br>response through its<br>contact with the skin. | Not a contact sensitizer<br>under the condition of<br>this test. | Not a contact sensitizer<br>There was no positive allergic<br>reaction observed during the<br>challenge phase (at 0, 24 hours and<br>48 hours) in animals treated with<br>the test material and negative<br>control | Pass |
| Biocompatibility<br>Cytotoxicity -<br>MEM Elution | ISO 10993-5:2009 | To assess cytotoxicity<br>reactivity caused by<br>this glove | At which level of extract<br>concentration, the glove<br>exhibits no cytotoxicity<br>reactivity under the<br>condition of this test. | Exhibit severe cytotoxicity reactivity<br>at 100%, 50%, and 25% extract<br>concentration.<br>No cytotoxicity reactivity at<br>12.5%, 6.25% and 3.125%<br>extract concentrations | Not Pass |
| Biocompatibility<br>Acute Systemic<br>Toxicity | ISO 10993-<br>11:2017 (E) | To demonstrate<br>adverse effect occurring<br>at any time within<br>72hours after single<br>exposure | no adverse biological<br>reaction under the<br>condition of this test. | no adverse biological reaction<br>under the condition of this test | Pass |

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### Summary of Clinical Testing 8.0

Not applicable - Clinical data was not used to assess performance of the subject device.

#### 9.0 Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Blue Colored, Powder Free Nitrile Examination Gloves, Nonsterile and tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K192954).