AspenMed+

K213076 · Aspen Glove Sdn. Bhd. · LZC · Dec 20, 2021 · General Hospital

Device Facts

• Record ID: K213076
• Device Name: AspenMed+
• Applicant: Aspen Glove Sdn. Bhd.
• Product Code: LZC · General Hospital
• Decision Date: Dec 20, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, blue nitrile examination glove; made from acrylonitrile-butadiene copolymer. Worn by healthcare professionals to prevent cross-contamination between patient and examiner. Tested for permeation resistance against specific chemotherapy drugs per ASTM D6978-05 (2019). Provides barrier protection; breakthrough times vary by drug; specific warning against use with Carmustine (BCNU) and Thiotepa due to low permeation times. Used in clinical settings.

Clinical Evidence

No clinical data. Bench testing only, including physical properties (tensile strength, elongation), dimensions, watertightness (ASTM D5151), residual powder (ASTM D6124), and biocompatibility (ISO 10993). Chemotherapy drug permeation testing performed per ASTM D6978-05.

Technological Characteristics

Material: Acrylonitrile-butadiene copolymer (nitrile). Form: Powder-free, blue, finger-textured, non-sterile. Dimensions: Length >230mm, width 95+/-10mm (medium). Physical properties: Tensile strength >14 MPa, ultimate elongation >500% (before aging). Standards: ASTM D6319-2019 (nitrile gloves), ASTM D6978-05(2019) (chemotherapy permeation), ISO 10993 (biocompatibility).

Indications for Use

Indicated for use as a disposable medical glove worn on the examiner's hand to prevent cross-contamination between patient and examiner. Tested for resistance to permeation by 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

• Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for use with Chemotherapy Drugs) (K210944)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 20, 2021

Aspen Glove Sdn. Bhd. Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504

Re: K213076

Trade/Device Name: Blue Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: September 18, 2021 Received: September 23, 2021

Dear Manoj Zacharias:

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.

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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); 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.

For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213076

#### Device Name

Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs

#### Indications for Use (Describe)

Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

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

| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|-----------------------------------------------|-------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 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)

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

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## K213076 510(K) SUMMARY As required by: 21CFR§807.92(c)

# A. APPLICANTINFORMATION

| 510(K) Owner's Name | Aspen Glove Sdn. Bhd. |
|---------------------|----------------------------------------------------------------------------------|
| Address | Aspen House, 300, JLN Macalister,<br>10450 Georgetown, Pulau Pinang,<br>Malaysia |
| Phone | [phone] |
| Fax | [phone] |
| E-mail | [e-mail] |
| Contact Person | Mr. Iskandar Basha bin Abdul Kadir |
| Designation | Managing Director |
| Contact Number | 017-550 0577 |
| Contact Email | [e-mail] |
| Date Submitted | 18 September 2021 |

#### B. DEVICE IDENTIFICATION

| Name of the device | Blue Nitrile Examination Gloves Powder Free tested<br>for use with Chemotherapy drugs |
|-----------------------------------|---------------------------------------------------------------------------------------|
| Product proprietary or trade name | AspenMed+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty |
| Device Classification | Class- I |
| Product Code | LZA, LZC |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |

#### C. PREDICATE DEVICE

| Predicate Device | Harbour Health<br>Powder Free Nitrile Examination Glove, Blue (Tested for<br>use with Chemotherapy Drugs) |
|------------------|-----------------------------------------------------------------------------------------------------------|
| 510( K) Number | K210944 |
| Regulatory Class | I |
| Product code | LZA, LZC, OPJ |

#### D. DESCRIPTION OF THEDEVICE:

The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs.

The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I).

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The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. 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(2019)

#### E. INTENDED USE OF THE DEVICE:

Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.

| Tested Chemotherapy Drug Name &<br>Concentration | Minimum Breakthrough Detection<br>Time (Minutes) |
|--------------------------------------------------|--------------------------------------------------|
| Carmustine (BCNU) (3.3 mg/ml) | 34.3 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 87.3 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |

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

hat the following drugs have low permeation times Carmustine (BCNU) (3.3 mg/ml) 34.3 Minutes Thiotepa (10 mg/ml) 87.3 Minutes

Warning: Do not use with Carmustine (BCNU) & Thiotepa

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#### F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | PREDICATE | PROPOSED<br>DEVICE | |
| 510(K) Number | | K210944 | K213076 | |
| Name of device | | Harbour Health<br>Powder Free<br>Nitrile<br>Examination<br>Glove, Blue<br>(Tested for use<br>with<br>Chemotherapy<br>Drugs) | Blue Nitrile<br>Examination Gloves<br>Powder Free tested<br>for use with<br>Chemotherapy drugs | Similar |
| Product Code | | LZA, LZC, OPJ | LZA, LZC | Similar |
| Intended use | | Harbour Health<br>Powder<br>Free<br>Nitrile<br>Examination<br>Glove, Blue<br>(Tested for use<br>with<br>Chemotherapy<br>Drugs) disposable<br>device<br>intended<br>for<br>medical<br>purpose that is<br>worn on the<br>examiner's hand<br>to<br>prevent<br>contamination<br>between patient<br>and examiner.<br>The<br>proposed<br>device was tested<br>for<br>use<br>with<br>chemotherapy<br>drugs as per<br>ASTM D6978-05<br>(2019), Standard<br>Practice<br>for<br>Assessment<br>of<br>Medical Gloves to<br>Permeation by<br>Chemotherapy<br>Drugs | Blue Nitrile<br>Examination Gloves<br>Powder Free tested<br>for use with<br>Chemotherapy drugs<br>is a disposable<br>device intended for<br>medical purpose that<br>is worn on the<br>examiner's hand to<br>prevent<br>contamination<br>between patient and<br>examiner.<br>Additionally,<br>the<br>gloves were tested<br>for use with<br>chemotherapy drugs<br>in accordance with<br>ASTM D6978-05<br>(2019) Standard<br>Practice<br>for<br>Assessment<br>of<br>Medical Glove to<br>Permeation by<br>Chemotherapy<br>Drugs. | Similar |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE<br>PREDICATE<br>K210944 | DEVICE PERFORMANCE<br>PROPOSED<br>DEVICE | REMARKS |
| Regulation Number | - | 21 CFR<br>880.6250 | 21 CFR<br>880.6250 | Same |
| Material | - | Nitrile | Nitrile | Same |
| Color | - | Blue | Blue | Same |
| Texture | - | Finger Texture | Finger texture | Same |
| Size | ASTM D6319-<br>2019 | Small, Large<br>Medium, Large,<br>Extra | Small, Medium,<br>Large, Extra<br>Large | Same |
| Single Use | Medical Glove<br>Guidance<br>Manual<br>- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-<br>2019 | Length: Small-<br>Min 220 mm &<br>Medium, Large<br>& Extra large-<br>Min 230 mm<br>Width Min<br>95+/-10 mm(<br>Medium Size) | Length > 230<br>mm<br>Width Min<br>95+/-10 mm(for<br>medium size) | Similar |
| Physical Properties | ASTM D6319-<br>2019 | Before Ageing<br>Tensile Strength<br>min 14 Mpa<br>Ultimate<br>Elongation<br>Min 500%<br>After Ageing<br>Tensile Strength<br>min 14 Mpa<br>Ultimate<br>Elongation<br>Min 400% | Before Ageing<br>Tensile Strength<br>> 14 Mpa<br>Ultimate<br>Elongation<br>>500%<br>After Ageing<br>Tensile Strength<br>>14 Mpa<br>Ultimate<br>Elongation<br>> 400% | Same |
| Thickness | ASTM D6319-<br>2019 | Palm<br>min 0.05 mm<br>Finger<br>min 0.05 mm | Palm >0.05 mm<br>Finger > 0.05<br>mm | Same |
| Powder Free<br>Residue | ASTM D6319-<br>2019 | <2 mg/glove | <2 mg/glove | Same |
| Watertight<br>(1000 ml) | ASTM D5151-<br>2019 | Passes AQL-2.5 | Passes AQL-1.5 | Similar |
| Label and Labeling | FDA Label<br>requirements | Meets FDA's<br>requirements | Meets FDA's<br>requirements | Same |
| CHARACTE<br>RSTICS | STANDARDS | DEVICE PERFORMANCE | | REMARKS |
| | | PREDICATE<br>K210944 | PROPOSED<br>DEVICE | |
| Bio-<br>compatibility | Primary Skin Irritation-<br>ISO 10993-10:2010<br>(E) | Under the condition<br>of study not an<br>irritant | Under the condition<br>of study not an<br>irritant | Same |
| | Dermal Sensitization-<br>ISO 10993-10:2010<br>(E) | Under the conditions<br>of the study not a<br>sensitizer | Under the conditions<br>of the study not a<br>sensitizer | Same |
| | In vitro cytotoxicity<br>ISO10993-5 :2009(E) | Under the<br>conditions of the<br>study, potentially<br>cytotoxic | Under the<br>conditions of the<br>study, cytotoxic | Similar |
| | Material<br>Mediated<br>Pyrogenicity<br>ISO 10993-<br>11:2017(E) /<br>USP 41<151> | No Data Available | Under the<br>conditions of the<br>study non<br>pyrogenic | ---- |
| | Acute Systemic Toxicity<br>Test ISO 10993-<br>11:2017(E) | Under the conditions<br>of the study, the<br>device does not<br>elicit a systemic<br>toxicity response in<br>the model animal | Under the condition<br>of study does not<br>induce any systemic<br>toxic concern | Similar |
| | Bacterial Endotoxin<br>test<br>USP 42<85> | No data available | <20EU/pair of<br>gloves | ---- |
| Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as tested per ASTM<br>D6978-05 (2019) | | | | |
| | Busulfan (6mg/ml) | >240 Minutes | Not Tested | Different |
| | Carmustine (BCNU) (3.3 mg/ml) | 14.5 Minutes | 34.3 Minutes | Different |
| | Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Cytarabine (100 mg/ ml) | >240 Minutes | Not Tested | Different |
| | Dacarbazine (10.0 mg/ml) | >240 Minutes | >240 Minutes | Same |
| | Docetaxel (10 mg/ml) | >240 Minutes | Not Tested | Different |
| Doxorubicin HCl (2 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Etoposide (20 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Fluorouracil (50 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Ifosfamide (50 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Mechlorethamine HCL (1 mg/ml) | | >240 Minutes | Not Tested | Different |
| Methotrexate (25 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| Mitomycin C (0.5 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| | Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Paclitaxel (6 mg/ml) | | >240 Minutes | >240 Minutes | Same |
| | Thiotepa (10 mg/ml) | 47.4 Minutes | 87.3 Minutes | Different |
| Vincristine Sulfate (1 mg/ml) | | >240 Minutes | >240 Minutes | Same |

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| | | | | G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA |
|--|--|--|--|--------------------------------------------------|
|--|--|--|--|--------------------------------------------------|

| Test Method | Purpose | Acceptance Criteria | Result |
|--------------------------------------------------------------------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>length of the gloves | Min 220 mm for Size Small<br>& Min 230 mm for all<br>other sizes | Small:- 245 mm<br>Medium:- 246 mm<br>Large:- 248 mm<br>X-Large:- 248 mm |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>width of the gloves | Small:- 80+/-10 mm<br>Medium:- 95+/-10 mm<br>Large:- 110+/-10 mm<br>X-Large:- 120+/-10 mm | Small:- 80 mm<br>Medium:- 92 mm<br>Large:- 105 mm<br>X-Large:- 115 mm |

| Test Method | Purpose | Acceptance Criteria | Result | | |
|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To determine the<br>thickness of the<br>gloves | Palm 0.05 mm min<br>Finger 0.05 mm min<br>for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large | Palm<br>0.09 mm<br>0.09 mm<br>0.09 mm<br>0.09 mm | Finger<br>0.15mm<br>0.15mm<br>0.15mm<br>0.15mm |
| ASTM D6319-2019 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Application | To Determine the<br>physical<br>properties-<br>Tensile strength | Before Ageing<br>Tensile Strength 14Mpa<br>Min for all sizes<br>After Ageing Tensile<br>Strength 14Mpa<br>Min<br>for all sizes | Size<br>Small<br>Medium<br>Large<br>X-Large | Before<br>ageing<br>18.52 Mpa<br>18.61 Mpa<br>18.67 Mpa<br>18.72 Mpa | After<br>ageing<br>17.54 Mpa<br>17.68 Mpa<br>17.74 Mpa<br>17.80 Mpa |
| ASTM D6319-2019 Standa…