← Product Code [LZA](/productcode/LZA) · K220401 # Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim (K220401) _Riverstone Resources Sdn Bhd · LZA · Apr 9, 2022 · General Hospital · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K220401 ## Device Facts - **Applicant:** Riverstone Resources Sdn Bhd - **Product Code:** [LZA](/productcode/LZA.md) - **Decision Date:** Apr 9, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6250 - **Device Class:** Class 1 - **Review Panel:** General Hospital ## Indications for Use Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim 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. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards. Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentanyl test claim ## Device Story Disposable, non-sterile, pink-colored, bubblegum-scented nitrile examination glove; intended for use by healthcare professionals or patients to prevent cross-contamination. Device functions as a physical barrier. Tested for permeation resistance against specific chemotherapy agents and fentanyl citrate per ASTM D6978-05. Used in clinical or home settings. Output is a protective barrier; healthcare providers use the glove to maintain hygiene during examinations and handling of hazardous drugs. Benefits include protection against patient-to-examiner contamination and exposure to specific chemotherapy agents. ## Clinical Evidence No clinical data. Bench testing only. Performance verified via ASTM D6319-10 (physical properties, dimensions, pinholes), ASTM D5151-06 (water leak), ASTM D6124-06 (residual powder), and ASTM D6978-05 (chemotherapy/fentanyl permeation). Biocompatibility assessed per ISO 10993-10 and ISO 10993-11. ## Technological Characteristics Material: Nitrile compound. Form factor: Disposable, powder-free, pink, bubblegum-scented glove. Dimensions: 230mm length, 0.05mm minimum thickness. Standards: ASTM D6319-10, ASTM D6978-05, ASTM D5151-06, ASTM D6124-06. Non-sterile. No electronic components or software. ## Regulatory 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 - Comfort Rubber Gloves Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate ([K192954](/device/K192954.md)) ## Reference Devices - SMART SHIELD POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT ([K991744](/device/K991744.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 9, 2022 Riverstone Resources Sdn Bhd Suresh Kumar OA Manager Lot 20852, No.119, Jalan Logam 7 Kamunting Raya Industrial Estate Taiping, Perak Darul Ridzuan 34600 Malaysia Re: K220401 Trade/Device Name: Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, ODO Dated: February 11, 2022 Received: February 11, 2022 Dear Suresh 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. 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. {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Bifeng Qian, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. ### 510(k) Number (if known) K220401 ### Device Name Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drug and Fentanyl Test Claim ### Indications for Use (Describe) Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim 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. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drug and Fentaryl test claim in accordance with ASTM D6978-05 standards. Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentaryl test claim Chemotherapy Drugs and Concentration Minimum Breakthrough Detection Time (Min), ug/cm2/minute - 1) Carmustine (BCNU) 3.3mg/ml 2) Cyclophosphamide (Cytoxan) (20mg/ml) 3) Cytarabine HCI (100mg/ml) 4) Doxorubicin HCI (2.0mg/ml) 5) Etoposide (20.0mg/ml 6) Fluorouracil (50.0mg/ml) 7) Methotrexate (25mg/ml) 8) Paclitaxel (6.0mg/ml) 9) ThioTepa (10.0mg/ml) 10) Fentanyl Citrate Injection 100mg/2ml >240 minutes >240 minutes >240 minutes >240 minutes >240 minutes >240 minutes 34.8 minutes >240 minutes 13.7 minutes >240 minutes The Maximum testing time is 240 minutes. Please note that the following drugs have extremely low Permeation time. Carmustine (BCNU) 3.3mg/ml ThioTeta (10.0mg/ml) Warning to do not use with Carmustine and Thio Tepa. 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. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Riverstone Resources Sdn. Bhd(229842-A) HQ: Lot 55 & 56, No. 13 Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit Beruntung, Selangor, Malaysia Taiping: Lot 20852, No 119, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak, Malavsia K220401 ## 510(K) Summary ## Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim #### 1.0 Submitter: | Company Name | Riverstone Resources Sdn Bhd. | |-----------------|----------------------------------------------------------------------------------------------------------------------------| | Company Address | Lot 20852, No.119, Jalan Logam 7,
Kamunting Raya Industrial Estate,
34600, Taiping, Perak Darul Ridzuan
Malaysia. | | Contact Person | Mr. Suresh Kumar | | Telephone | +605-8912777 | | Fax | + 605-8912999 | | Email | qa1@riverstone.com.my | - 2.0 : 7th April 2022 Preparation Date #### 3.0 Name of the Device Trade Name / Proprietary Name : Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim Device Name: Nitrile Patient Examination gloves. Device Classification Name: Patient Examination gloves (21 CFR 880.6250). Device Class: Class I. Product Code: LZA, LZC, QDO {5}------------------------------------------------ HQ: Lot 55 & 56, No. 13 Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit Beruntung, Selangor, Malaysia Taiping: Lot 20852, No 119, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak, Malavsia K220401 #### 4.0 Identification of The Legally Marketed Device: Reference Device: K991744, SMART SHIELD POWDER FREE COLORED NITRILE EXAMINATION GLOVES WITH BUBBLE GUM SCENT Predicate Device: K192954 BLUE COLORED. POWDER FREE NITRICE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL CITRATE. #### 5.0 Device Description The subject device in this 510(k) Notification is Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim. The subject device is a patient examination glove made from nitrile compound, pink 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/Indication for Use Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim 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. It is for over-the-counter use. In addition, these gloves were tested for use with Chemotherapy drug and Fentanyl test claim in accordance with ASTM D6978-05 standards Practice for assessment of Medical Glove to Permeation by chemotherapy drug and Fentanyl test claim | Chemotherapy Drug and Fentanyl Test Claim
Concentration | Minimum Breakthrough detection
time in Minutes, ug/cm²/minute | |------------------------------------------------------------|------------------------------------------------------------------| | Carmustine (BCNU) 3.3mg/ml | 13.7 minutes | | Cyclophosphamide (Cytoxan) (20mg/ml) | >240 minutes | | Cytarabine HCI (100mg/ml) | >240 minutes | | Doxorubicin HCI (2.0mg/ml) | >240 minutes | | Etoposide (20.0mg/ml | >240 minutes | | Fluorouracil (50.0mg/ml) | >240 minutes | | Methotrexate (25mg/ml) | >240 minutes | | Paclitaxel (6.0mg/ml) | >240 minutes | | ThioTepa (10.0mg/ml) | 34.8 minutes | | Fentanyl Citrate Injection 100mg/2ml | >240 minutes | The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time. Carmustine (BCNU) (3.3mg/ml)- Minimum Breakthrough detection time 13.7 ug/cm2/minute. Thiotepa (10ug/ml) - Minimum Breakthrough detection time 34.8 ug/cm²/minute. Warning to do not use with Carmustine and Thio Tepa {6}------------------------------------------------ HQ: Lot 55 & 56, No. 13 Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit Beruntung, Selangor, Malaysia Taiping: Lot 20852, No 119, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak, Malaysia K220401 #### 7.0 Specification for Nitrile gloves: #### Dimension and Thickness of Gloves 7.1 | Dimension | Size S | Size M | Size L | Size XL | |------------------------------|---------|---------|---------|---------| | Overall Length (mm) | 230min | 230min | 230min | 230min | | Width (± 5mm) | 85 | 95 | 105 | 115 | | Thickness at Palm (mm) | 0.05min | 0.05min | 0.05min | 0.05min | | Thickness at Finger Tip (mm) | 0.05min | 0.05min | 0.05min | 0.05min | #### 7.2 Gloves Physical Properties and Holes | Measurement | Before Ageing | After Aging at 70℃ for
168 hrs @ 100℃ for 22 hrs | |-------------------------|---------------------------------|-----------------------------------------------------| | Tensile Strength (MPa) | 14min | 14 Min | | Ultimate Elongation (%) | 500min | 400min | | Pin-hole Level | AQL 2.5
Inspection Level G-1 | AQL 2.5
Inspection Level G-1 | Gloves meet all the specification listed in ASTM D 6319-10 {7}------------------------------------------------ HQ: Lot 55 & 56, No. 13 Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit Beruntung, Selangor, Malaysia Taiping: Lot 20852, No 119, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak, Malaysia K220401 | Characteristics | Acceptance Criteria | Current Device | Reference Device | Predicate Device | Assessment
Similarities
and
Difference | |------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | Pink Powder Free Nitrile
Examination Glove with
Bubblegum Scented,
Chemotherapy Drugs and
Fentanyl test claim,
K220401 | Smart Shield Powder
Free Colored Nitrile
Examination Gloves
with Bubble Gum
Scent K991744 | Comfort Rubber Gloves
Powder Free Nitrile
Examination Gloves
Tested for Use with
Chemotherapy Drugs
and Fentanyl Citrate
K192954 | | | Product Code | LZA. | LZA, LZC and QDO | LZA. | LZA, LZC and QDO | Same | | 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. The
device is for over-the-
counter 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. The
device is for over-the-
counter 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. The device
is for over-the-counter
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. The
device is for over-the-
counter use. | same | | Material use | Nitrile
compound | Nitrile
compound | Nitrile
compound | Nitrile
compound | same | | Colour | | Pink | Blue | Blue | Different | | Sterility | Non sterile | Non sterile | Non sterile | Non sterile | same | | Single used | Single used | Single used | Single used | Single used | same | | Non Sterile | Non Sterile | Non Sterile | Non Sterile | Non Sterile | same | | Dimensions | Overall Length (mm)
Min 230mm
Width (± 5mm)
Size S = 85mm
Size M = 95mm
Size L = 105mm
Size XL = 115mm
Thickness at Palm (mm)
Min; 0.05 mm
Thickness at Finger Tip
(mm)
Min 0.05 mm | Meets
ASTM D6319-10 | Meets
ASTM D6319-10 | Meets
ASTM D6319-10 | same | | Physical
properties | Before Ageing
Tensile Strength (MPa)
= 14min
Ultimate Elongation (%)
= 500min
After Aging at 70℃ for
168 hrs @ 100℃ for 22
hrs
Tensile Strength (MPa)
= 14min
Ultimate Elongation (%)
= 100 | Meets
ASTM D6319-10 | Meets
ASTM D6319-10 | Meets
ASTM D6319-10 | same | | | | | | K220401 | | | Characteristics | Acceptance Criteria | Current Device | Reference Device | Predicate Device | Assessment
Similarities
and
Differences | | | | Pink Powder Free Nitrile
Examination Glove with
Bubblegum Scented,
Chemotherapy Drugs and
Fentanyl test claim,
K220401 | Smart Shield Powder
Free Colored Nitrile
Examination Gloves
with Bubble Gum
Scent K991744 | Comfort Rubber Gloves
Powder Free Nitrile
Examination Gloves
Tested for Use with
Chemotherapy Drugs
and Fentanyl Citrate
K192954 | | | Freedom from
pinholes | AQL 2.5
Inspection Level G-1 | Meets
ASTM D5151-06 | Meets
ASTM D5151-06 | Meets
ASTM D5151-06 | same | | Residual Powder | $≤$ 2.0 mg/pc | Meets
ASTM D6124-06 | Meets
ASTM D6124-06 | Meets
ASTM D6124-06 | same | | Biocompatibility | ISO 10993-10- Biological
Evaluation on
Medical Device -
-Primary Skin Irritation
Test | Passes
Under the conditions of this
study, the test article was a
non-irritant. | Passes
Under the conditions
of this study, the test
article was a non-
irritant. | Passes
Under the conditions of
this study, the test article
was a non-irritant. | same | | | ISO 10993-10- 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. | same | | | ISO 10993-11 - Acute
Systemic Test | Not inducing any acute
systemic toxicity. | did not provide acute
systemic toxicity
testing | Not inducing any acute
systemic toxicity | Same | | Resistance
against
Chemotherapy
Drugs | Standards Practice for
Assessment of resistance
of Medical Glove to
Permeation by
Chemotherapy drugs
ASTM D6978-05 | 1) Carmustine (BCNU)
3.3mg/ml
13.7 minutes
2) Cyclophosphamide
(Cytoxan)
(20mg/ml) >240
minutes
3) Cytarabine HCI
(100mg/ml)
>240
minutes
4) Doxorubicin HCI
(2.0mg/ml)
>240
minutes
5) Etoposide
(20.0mg/ml)
>240 minutes
6) Fluorouracil
(50.0mg/ml)
>240 minutes
7) Methotrexate
(25mg/ml)
>240 | No Chemotherapy was
tested | 1) Carmustine (BCNU)
3.3mg/ml
10.1 minutes
2) Cyclophosphamide
(Cytoxan)
(20mg/ml) >240
minutes
3) Cytarabine HCI
(100mg/ml)
0 minutes
4) Doxorubicin HCI
(2.0mg/ml)
>240
minutes
5) Etoposide
(20.0mg/ml)
>240 minutes
6) Fluorouracil
(50.0mg/ml)
>240 minutes
7) Methotrexate
(25mg/ml)
>240 | Similar - The
Chemotherapy
drugs tested
have similar
breakthrough
detection
times; the
drugs with low
permeation
>24 times for the
510K is similar
than predicate
device | | Characteristics | Acceptance Criteria | Current Device | Reference Device | Predicate Device | Assessment
Similarities
and
Differences | | | | Pink Powder Free Nitrile
Examination Glove with
Bubblegum Scented,
Chemotherapy Drugs and
Fentanyl test claim,
K220401 | Smart Shield Powder
Free Colored Nitrile
Examination Gloves
with Bubble Gum
Scent K991744 | Comfort Rubber Gloves
Powder Free Nitrile
Examination Gloves
Tested for Use with
Chemotherapy Drugs
and Fentanyl Citrate
K192954 | | | | | 8) Paclitaxel (6.0mg/ml)
240 minutes
9) ThioTepa (10.0mg/ml)
34.8 minutes
10) Fentanyl Citrate Injection,
100mg/2ml >240 minutes | > | 8) Paclitaxel (6.0mg/ml)
>240 minutes
9) ThioTepa (10.0mg/ml)
30.2 minutes
10) Fentanyl Citrate Injection,
100mg/2ml >240 minutes | | ## Comparison of Proposed and Predicate Device 400min {8}------------------------------------------------ HQ: Lot 55 & 56, No. 13 Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit Beruntung, Selangor, Malaysia Taiping: Lot 20852, No 119, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak, Malaysia {9}------------------------------------------------ HQ: Lot 55 & 56, No. 13 Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit Beruntung, Selangor, Malaysia Taiping: Lot 20852, No 119, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak, Malaysia | Performance data of gloves based on ASTM D6319 -10 and FDA 1000ml water leak test | | | | | | |-----------------------------------------------------------------------------------|-----------------------------|-----------------------------------|----------------------------------------|-----------------------------------------------------------|--------| | Characteristics | Test | Test standard | Sampling plan / Inspection level / AQL | Nitrile Examination Powder Free | Result | | Freedom from Pin holes | FDA 1000 ml water leak test | ASTM D5151 -06 (Re-approved 2011) | ISO 2859-1/ G1/AQL 2.5 | Meet AQL 2.5 | Pass | | Dimensions | Length | ASTM D6319 -10 | ISO 2859-1/ S2/AQL 4.0 | Min 230 | Pass | | | Width | ASTM D6319 -10 | ISO 2859-1/ S2/AQL 4.0 | 85±5 mm to 115±5 mm (sizes Small to Extra Large) | Pass | | | Thickness | ASTM D6319 -10 | ISO 2859-1/ S2/AQL 4.0 | >0.05mm (Palm, finger) | Pass | | Physical properties | Before aging | ASTM D6319 -10
ASTM D412-06 | ISO 2859-1/ S2/AQL 4.0 | Tensile strength: > 14 Mpa Ultimate
Elongation : >500% | Pass | | | After Accelerated aging | ASTM D6319 -10 and ASTM D412-06 | ISO 2859-1/ S2/AQL 4.0 | Tensile strength: > 14 Mpa
Ultimate Elongation: > 400% | Pass | | | Powder-free residue | ASTM D6124-06 | N=5 | Less than 2 mg per glove | Pass | | Powder-free residue | Powder-free residue | ASTM D6124-06 | N=5 | Less than 2 mg per glove | Pass | #### 8.0 Summary of Clinical Testing Clinical testing was not needed for this device under this section {10}------------------------------------------------ HQ: Lot 55 & 56, No. 13 Jalan Jasmin 2,Kawasan Perindustrian Bukit Beruntung,48300 Bukit Beruntung, Selangor, Malaysia Taiping: Lot 20852, No 119, Jalan Logam 7, Kamunting Raya Industrial Estate, 34600 Taiping, Perak, Malaysia K220401 #### 9.0 Conclusion The Conclusion drawn from the non-Clinical test demonstrates that the subject device in 510(K) Submission, Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl test claim is as safe, as effective, and performs as well as or better than the legally marketed Predicate device cleared under K192954. --- **Source:** [https://fda-staging.innolitics.com/device/K220401](https://fda-staging.innolitics.com/device/K220401) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com