(57 days)
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
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.
This document is a 510(k) premarket notification for a medical device: "Pink Powder Free Nitrile Examination Glove with Bubblegum Scented, Chemotherapy Drugs and Fentanyl Test Claim." Since this is a glove, the criteria are focused on physical and chemical properties and safety, not on diagnostic accuracy of an AI model. Therefore, many of the requested categories related to AI performance, such as MRMC studies, expert adjudication, training sets, and data provenance in a diagnostic sense, are not applicable.
Below is the information derived from the provided document, tailored to the context of a medical glove.
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was evaluated against ASTM standards and specific chemical resistance criteria.
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Overall Length | Min 230mm | Meets ASTM D6319-10 (implying >230mm for all sizes) |
| Width | Size S = 85±5mm; Size M = 95±5mm; Size L = 105±5mm; Size XL = 115±5mm | Meets ASTM D6319-10 (specific widths 85mm, 95mm, 105mm, 115mm) |
| Thickness | Palm: Min 0.05 mm; Finger Tip: Min 0.05 mm | Meets ASTM D6319-10 (implying >0.05mm at palm and finger) |
| Physical Properties | ||
| Before Ageing | Tensile Strength (MPa) = ≥14min; Ultimate Elongation (%) = ≥500min | Meets ASTM D6319-10 |
| After Ageing | Tensile Strength (MPa) = ≥14min; Ultimate Elongation (%) = ≥400min (at 70℃ for 168 hrs / 100℃ for 22 hrs) | Meets ASTM D6319-10 |
| Pin-hole Level | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (AQL 2.5, Inspection Level G-1) by FDA 1000ml water leak test |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 (< 2 mg per glove) |
| Biocompatibility | Primary Skin Irritation Test: Non-irritant | Passes (test article was a non-irritant) |
| Dermal Sensitization Assay: Non-sensitizer | Passes (test article was a non-sensitizer) | |
| Acute Systemic Test: Not inducing any acute systemic toxicity | Not inducing any acute systemic toxicity | |
| Resistance against Chemotherapy Drugs (ASTM D6978-05 standard) | ||
| 1) Carmustine (BCNU) 3.3mg/ml | ≥ 10.1 minutes (based on predicate) | 13.7 minutes |
| 2) Cyclophosphamide (Cytoxan) (20mg/ml) | >240 minutes | >240 minutes |
| 3) Cytarabine HCI (100mg/ml) | ≥ 0 minutes (based on predicate which was 0 minutes, but new claims >240 minutes) | >240 minutes |
| 4) Doxorubicin HCI (2.0mg/ml) | >240 minutes | >240 minutes |
| 5) Etoposide (20.0mg/ml) | >240 minutes | >240 minutes |
| 6) Fluorouracil (50.0mg/ml) | >240 minutes | >240 minutes |
| 7) Methotrexate (25mg/ml) | >240 minutes | >240 minutes |
| 8) Paclitaxel (6.0mg/ml) | >240 minutes | >240 minutes |
| 9) ThioTepa (10.0mg/ml) | ≥ 30.2 minutes (based on predicate) | 34.8 minutes |
| 10) Fentanyl Citrate Injection 100mg/2ml | >240 minutes | >240 minutes |
2. Sample size used for the test set and data provenance
- Sample Size for Physical/Chemical Testing:
- For Freedom from Pin holes (AQL 2.5): ISO 2859-1/ G1 inspection level. The specific numerical sample size is not explicitly stated but is determined by the AQL and inspection level, which is a standard sampling plan for quality control in manufacturing.
- For Dimensions (AQL 4.0): ISO 2859-1/ S2 inspection level.
- For Physical properties (AQL 4.0): ISO 2859-1/ S2 inspection level.
- For Powder-free residue: N=5 gloves tested.
- For Biocompatibility: The exact number of samples (animals or cell cultures) used for biocompatibility testing is not specified in this summary but generally follows ISO 10993 guidelines.
- For Chemotherapy Drugs and Fentanyl Permeation: The specific sample size for each drug test is not explicitly stated in this document but these tests typically involve multiple glove samples.
- Data Provenance: The tests were conducted by Riverstone Resources Sdn Bhd, a Malaysian company. The data is retrospective (i.e., tests were completed before the 510(k) submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a medical glove, and "ground truth" as it relates to expert clinical assessments for diagnostic algorithms is not relevant here. The "ground truth" for the performance criteria is established by adherence to recognized international standards (ASTM, ISO) for physical, chemical, and biological properties.
4. Adjudication method for the test set
Not applicable. The testing involves standardized laboratory methods and measurements, not subjective interpretation requiring adjudication among experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are used for evaluating the diagnostic performance of imaging devices or AI algorithms by comparing multiple human readers' interpretations of cases. This is a physical device (glove), not a diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The performance tests are for the physical and chemical properties of the glove itself.
7. The type of ground truth used
The "ground truth" is based on:
- Standardized Test Methods: Adherence to established international standards such as ASTM D6319-10 (Standard specification for Nitrile Examination Gloves), ASTM D5151-06 (Freedom from Pinholes), ASTM D6124-06 (Powder-free residue), ASTM D6978-05 (Chemotherapy drug permeation), and ISO 10993 series (Biocompatibility).
- Predicate Device Performance: For chemotherapy drug permeation, the performance of the predicate device (K192954) also serves as a benchmark for comparison.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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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.
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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 (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
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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: 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
-
- 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.
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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
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 RidzuanMalaysia. |
| Contact Person | Mr. Suresh Kumar |
| Telephone | +605-8912777 |
| Fax | + 605-8912999 |
| 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
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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
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 ClaimConcentration | Minimum Breakthrough detectiontime 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
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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
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℃ for168 hrs @ 100℃ for 22 hrs |
|---|---|---|
| Tensile Strength (MPa) | 14min | 14 Min |
| Ultimate Elongation (%) | 500min | 400min |
| Pin-hole Level | AQL 2.5Inspection Level G-1 | AQL 2.5Inspection Level G-1 |
Gloves meet all the specification listed in ASTM D 6319-10
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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
| Characteristics | Acceptance Criteria | Current Device | Reference Device | Predicate Device | AssessmentSimilaritiesandDifference |
|---|---|---|---|---|---|
| Pink Powder Free NitrileExamination Glove withBubblegum Scented,Chemotherapy Drugs andFentanyl test claim,K220401 | Smart Shield PowderFree Colored NitrileExamination Gloveswith Bubble GumScent K991744 | Comfort Rubber GlovesPowder Free NitrileExamination GlovesTested for Use withChemotherapy Drugsand Fentanyl CitrateK192954 | |||
| Product Code | LZA. | LZA, LZC and QDO | LZA. | LZA, LZC and QDO | Same |
| Intended use | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use. | A powder free patientexamination glove is adisposable device intendedfor medical purposes that isworn on the examiner'shand or finger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use. | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is wornon the examiner'shand or finger toprevent contaminationbetween patient andexaminer. The deviceis for over-the-counteruse. | A powder free patientexamination glove is adisposable deviceintended for medicalpurposes that is worn onthe examiner's hand orfinger to preventcontamination betweenpatient and examiner. Thedevice is for over-the-counter use. | same |
| Material use | Nitrilecompound | Nitrilecompound | Nitrilecompound | Nitrilecompound | 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 230mmWidth (± 5mm)Size S = 85mmSize M = 95mmSize L = 105mmSize XL = 115mmThickness at Palm (mm)Min; 0.05 mmThickness at Finger Tip(mm)Min 0.05 mm | MeetsASTM D6319-10 | MeetsASTM D6319-10 | MeetsASTM D6319-10 | same |
| Physicalproperties | Before AgeingTensile Strength (MPa)= 14minUltimate Elongation (%)= 500minAfter Aging at 70℃ for168 hrs @ 100℃ for 22hrsTensile Strength (MPa)= 14minUltimate Elongation (%)= 100 | MeetsASTM D6319-10 | MeetsASTM D6319-10 | MeetsASTM D6319-10 | same |
| K220401 | |||||
| Characteristics | Acceptance Criteria | Current Device | Reference Device | Predicate Device | AssessmentSimilaritiesandDifferences |
| Pink Powder Free NitrileExamination Glove withBubblegum Scented,Chemotherapy Drugs andFentanyl test claim,K220401 | Smart Shield PowderFree Colored NitrileExamination Gloveswith Bubble GumScent K991744 | Comfort Rubber GlovesPowder Free NitrileExamination GlovesTested for Use withChemotherapy Drugsand Fentanyl CitrateK192954 | |||
| Freedom frompinholes | AQL 2.5Inspection Level G-1 | MeetsASTM D5151-06 | MeetsASTM D5151-06 | MeetsASTM D5151-06 | same |
| Residual Powder | $≤$ 2.0 mg/pc | MeetsASTM D6124-06 | MeetsASTM D6124-06 | MeetsASTM D6124-06 | same |
| Biocompatibility | ISO 10993-10- BiologicalEvaluation onMedical Device --Primary Skin IrritationTest | PassesUnder the conditions of thisstudy, the test article was anon-irritant. | PassesUnder the conditionsof this study, the testarticle was a non-irritant. | PassesUnder the conditions ofthis study, the test articlewas a non-irritant. | same |
| ISO 10993-10- BiologicalEvaluation onMedical Device -Dermal SensitizationAssay | Under the conditions of thisstudy, the test article was anon-sensitizer. | Under the conditionsof this study, the testarticle was a non-sensitizer. | Under the conditions ofthis study, the test articlewas a non-sensitizer. | same | |
| ISO 10993-11 - AcuteSystemic Test | Not inducing any acutesystemic toxicity. | did not provide acutesystemic toxicitytesting | Not inducing any acutesystemic toxicity | Same | |
| ResistanceagainstChemotherapyDrugs | Standards Practice forAssessment of resistanceof Medical Glove toPermeation byChemotherapy drugsASTM D6978-05 | 1) Carmustine (BCNU)3.3mg/ml13.7 minutes2) Cyclophosphamide(Cytoxan)(20mg/ml) >240minutes3) Cytarabine HCI(100mg/ml)>240minutes4) Doxorubicin HCI(2.0mg/ml)>240minutes5) Etoposide(20.0mg/ml)>240 minutes6) Fluorouracil(50.0mg/ml)>240 minutes7) Methotrexate(25mg/ml)>240 | No Chemotherapy wastested | 1) Carmustine (BCNU)3.3mg/ml10.1 minutes2) Cyclophosphamide(Cytoxan)(20mg/ml) >240minutes3) Cytarabine HCI(100mg/ml)0 minutes4) Doxorubicin HCI(2.0mg/ml)>240minutes5) Etoposide(20.0mg/ml)>240 minutes6) Fluorouracil(50.0mg/ml)>240 minutes7) Methotrexate(25mg/ml)>240 | Similar - TheChemotherapydrugs testedhave similarbreakthroughdetectiontimes; thedrugs with lowpermeation>24 times for the510K is similarthan predicatedevice |
| Characteristics | Acceptance Criteria | Current Device | Reference Device | Predicate Device | AssessmentSimilaritiesandDifferences |
| Pink Powder Free NitrileExamination Glove withBubblegum Scented,Chemotherapy Drugs andFentanyl test claim,K220401 | Smart Shield PowderFree Colored NitrileExamination Gloveswith Bubble GumScent K991744 | Comfort Rubber GlovesPowder Free NitrileExamination GlovesTested for Use withChemotherapy Drugsand Fentanyl CitrateK192954 | |||
| 8) Paclitaxel (6.0mg/ml)240 minutes9) ThioTepa (10.0mg/ml)34.8 minutes10) Fentanyl Citrate Injection,100mg/2ml >240 minutes | > | 8) Paclitaxel (6.0mg/ml)>240 minutes9) ThioTepa (10.0mg/ml)30.2 minutes10) Fentanyl Citrate Injection,100mg/2ml >240 minutes |
Comparison of Proposed and Predicate Device
400min
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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
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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 -10ASTM D412-06 | ISO 2859-1/ S2/AQL 4.0 | Tensile strength: > 14 Mpa UltimateElongation : >500% | Pass |
| After Accelerated aging | ASTM D6319 -10 and ASTM D412-06 | ISO 2859-1/ S2/AQL 4.0 | Tensile strength: > 14 MpaUltimate 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
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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
9.0 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.
§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.