(45 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Cisplatin 1.0 mg/ml ≥ 240 Minutes
Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes
Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes
Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes
Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes
Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes
Methotrexate 25 mg/ml ≥ 240 Minutes
Mitomycin C 0.5 mg/ml ≥ 240 Minutes
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes
Thio-Tepa 10.0 mg/ml 87.0 Minutes
Not recommended for use with these drugs.
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.
The provided document is a 510(k) Premarket Notification for SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. It details the acceptance criteria and performance data for this medical device, which is a non-powdered patient examination glove.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥ 220, M/L/XL: ≥ 230Width (mm): S: 80 ± 10, M: 95 ± 10, L: 110 ± 10, XL: 120 ± 10Thickness (mm): Finger: ≥ 0.05, Palm: ≥ 0.05 | Length (mm): S: ≥ 220 / Pass, M/L/XL: ≥ 230 / PassWidth (mm): S: 82 – 85 / Pass, M: 95 – 97 / Pass, L: 103 – 107 / Pass, XL: 110 – 116 / PassThickness (mm): Finger: 0.13 – 0.17 / Pass, Palm: 0.09 – 0.11 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | S: 1/125 / Pass, M: 2/125 / Pass, L: 2/125 / Pass, XL: 4/125 / Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | 0.4 mg / Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 500%Meet the requirements of ASTM D412 AQL 4.0 | Tensile Strength: 14 – 19 MPa / PassUltimate Elongation: 515 – 540% / Pass1/13 / Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 400% | Tensile Strength: 15 – 20 / PassUltimate Elongation: 468 – 525 / Pass |
| ISO 10993-5 | Cytotoxicity | Non-In Vitro Cytotoxicity | Under conditions of the study, device extract is cytotoxic. (This result seems to contradict "Non-In Vitro Cytotoxicity" as an acceptance criterion unless the intended criterion was 'not cytotoxic' and the result indicates it did not meet this specific aspect, or it's phrased poorly and means no in-vitro cytotoxicity observed that would deem it unsafe). Correction: The phrasing in the document is "Under conditions of the study, device extract is cytotoxic." which implies failure if the acceptance criteria truly was "Non-In Vitro Cytotoxicity". However, given the overall conclusion of substantial equivalence, this specific wording might be an error or interpreted differently. |
| ISO 10993-11 | Acute Systemic Toxicity | Non-Acute Systemic Toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of the study, not an irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. / Pass |
| ASTM D6978-05 | Permeation by Chemotherapy Drugs | Breakthrough times for various chemotherapy drugs. (Specific numerical criteria for individual drugs are not explicitly stated as "acceptance criteria" but are implied by the predicate comparison and the statement that some drugs are "Not recommended for use.") | Breakthrough times reported for various chemotherapy drugs, including specific times for Carmustine (35.8 Minutes) and Thio-Tepa (87.0 Minutes). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the overall sample sizes for all tests beyond what is indicated in specific test results (e.g., in ASTM D5151, the number of gloves tested per size is implied by the X/125 format, and in ASTM D412 AQL, 1/13 is mentioned). The provenance of the data (e.g., country of origin, retrospective or prospective) is not mentioned. The tests are non-clinical, meaning they are laboratory-based, not patient-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a physical medical glove undergoing non-clinical performance testing. The "ground truth" is established by adherence to recognized ASTM and ISO standards for physical, chemical, and biocompatibility properties. There are no human experts involved in establishing a "ground truth" in the way one would for diagnostic imaging. The measurements are objective, per standard protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions. The performance is assessed against predefined statistical and physical thresholds in standardized tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on scientific and engineering standards for material properties, dimensions, physical performance, and biocompatibility, as defined by ASTM International and ISO. Examples include:
- Physical Dimensions: Measured and compared against ranges specified in ASTM D6319.
- Watertightness: Assessed by the AQL (Acceptable Quality Level) specified in ASTM D5151.
- Biocompatibility: Determined by adherence to ISO 10993 standards for cytotoxicity, systemic toxicity, irritation, and sensitization.
- Chemotherapy Drug Permeation: Measured breakthrough times as per ASTM D6978-05.
8. The sample size for the training set
Not applicable. This device is a medical glove, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
November 7, 2022
SafeSource Direct, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K222898
Trade/Device Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: October 31, 2022 Received: November 1, 2022
Dear Prithul Bom:
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.
Allan Gu
For Bifeng Oian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Not recommended for use with these drugs.
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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Image /page/3/Picture/2 description: The image contains the logo for SafeSource Direct. The logo consists of a shield with a red background and a blue "S" shape in the center. To the right of the shield is the text "SafeSource" in a bold, sans-serif font. Below "SafeSource" is the word "Direct" in the same font, and below that is the phrase "Personal Protective Equipment" in a smaller, lighter font.
510(k) Summary K222898
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Traditional 510(k) premarket notification.
| Sponsor: | SafeSource Direct, LLC200 St Nazaire Rd.Broussard, LA 70518Sponsor Contact: Justin Hollingsworth |
|---|---|
| Submission Contact: | Grace Powers, MS, MBA, RACFounder/Principal ConsultantPowers Regulatory ConsultingTel: 404-931-8730 |
| Preparation Date: | October 30, 2022 |
Subject Device:
Trade Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Common/Usual Name: Non-Powdered Patient Examination Glove Classification Name: Non-Powdered Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, OPJ Device Class: Class I, Reserved Classification Panel: General Hospital and Personal Use Devices
Predicate Device: Legally marketed device to which substantial equivalence is claimed: Trade/Proprietary Name: Medline Powder-Free Light Blue Nitrile Exam Gloves Manufacturer: Medline Industries, Inc. 510(k): K201390 Common/Usual Name: Non-Powdered Patient Examination Glove Classification Name: Patient Examination Glove, Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC Device Class: Class I, Reserved Classification Panel: General Hospital and Personal Use Devices
Device Description
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent
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Traditional 510(k) - SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.Physical performance of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application (FR Recognition Number 6-446).
In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (FR Recognition Number 6-147).
Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Not recommended for use with these drugs.
The gloves are available over the counter.
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Technological Characteristics
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves has similar technological characteristics as the predicate device.
| Table 1 – General Comparison | |||
|---|---|---|---|
| DeviceComparison | Subject Device:SafeSource Direct BluePowder-Free Nitrile ExamGloves(K222898) | Predicate Device:Medline Powder-Free LightBlue Nitrile Exam Gloves(K201390) | Comparison |
| Device | SafeSource Direct BluePowder-Free Nitrile ExamGloves | Medline Powder-Free LightBlue Nitrile Exam Gloves | Not Applicable |
| Manufacturer | SafeSource Direct, LLC | Medline Industries, Inc. | Not Applicable |
| FDA ProductCode | LZA, LZC, OPJ | LZA, LZC | Identical |
| RegulationName | Non-powdered PatientExaminationGlove, Specialty | Non-powdered PatientExaminationGlove, Specialty | Identical |
| RegulationNumber | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Intended Use/Indications forUse | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handsto prevent contaminationbetween patient andexaminer. These gloves weretested for use withchemotherapy drugs, as perASTM D6978-05 (Reapproved2019) Standard Practice forAssessment of Medical Glovesto Permeation byChemotherapy Drugs.Carmustine (BCNU) 3.3 mg/ml35.8 MinutesCisplatin 1.0 mg/ml ≥ 240MinutesCyclophosphamide (Cytoxan)20.0 mg/ml ≥ 240 MinutesDacarbazine (DTIC) 10.0mg/ml ≥ 240 MinutesDoxorubicin Hydrochloride2.0 mg/ml ≥ 240 MinutesEtoposide (Toposar) 20.0mg/ml ≥ 240 Minutes | A patient examination glove isa disposable device intendedfor medical purposes that isworn on the examiner's handsto prevent contaminationbetween patient andexaminer. These gloves weretested for use withchemotherapy drugs, as perASTM D6978-05 (Reapproved2019) Standard Practice forAssessment of Medical Glovesto Permeation byChemotherapy Drugs.Carmustine (BCNU) 3.3 mg/ml25.3 MinutesCisplatin 1.0 mg/ml ≥ 240MinutesCyclophosphamide (Cytoxan)20.0 mg/ml ≥ 240 MinutesDacarbazine (DTIC) 10.0mg/ml ≥ 240 MinutesDoxorubicin Hydrochloride2.0 mg/ml ≥ 240 MinutesEtoposide (Toposar) 20.0mg/ml ≥ 240 Minutes | Identical withthe exception ofthe Carmustineand Thio-Tepabreakthroughtimes. |
| Device Comparison | Subject Device:SafeSource Direct BluePowder-Free Nitrile ExamGloves | Predicate Device:Medline Powder-Free LightBlue Nitrile Exam Gloves(K201390) | Comparison |
| Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 MinutesMethotrexate 25 mg/ml ≥ 240 MinutesMitomycin C 0.5 mg/ml ≥ 240 MinutesPaclitaxel (Taxol) 6.0 mg/ml ≥ 240 MinutesThio-Tepa 10.0 mg/ml 87.0 MinutesVincristine Sulfate (Oncovin) 43.7 mg/ml ≥ 240 MinutesPlease note that the following drugs have low permeation times:Carmustine (BCNU) 3.3 mg/ml 35.8 MinutesThio-Tepa 10.0 mg/ml 87.0 MinutesNot recommended for use with these drugs. | Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 MinutesMethotrexate 25 mg/ml ≥ 240 MinutesMitomycin C 0.5 mg/ml ≥ 240 MinutesPaclitaxel (Taxol) 6.0 mg/ml ≥ 240 MinutesThio-Tepa 10.0 mg/ml 43.7 MinutesVincristine Sulfate (Oncovin) 43.7 mg/ml ≥ 240 MinutesPlease note that the following drugs have low permeation times:Carmustine (BCNU) 3.3 mg/ml 25.3 MinutesThio-Tepa 10.0 mg/ml 43.7 MinutesCaution: Testing showed an average breakthrough time of 43.7 minutes with Thio-TepaWARNING: Do not use with Carmustine | ||
| Sizes | Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large | Similar- the subject device does not come in extra small. |
| Materials | Nitrile | Nitrile | Similar |
| Color | Blue | Blue | Identical |
| Condition of Use | Single Use (Disposable) | Single Use (Disposable) | Identical |
| Powder orPowder-Free | Powder free | Powder Free | Identical |
| Dimensions-Length | Complies with ASTM D6319-19240mm min. | Complies with ASTM D6319-10240mm min. | Identical |
| Dimensions-Width | Complies with ASTM D6319-19S: 80±10mmM: 95±10mmL: 110±10mmXL: 120±10mm | Complies with ASTM D6319-10XS: N/AS: 85±10mmM: 95±10mmL: 105±10mm | Similar- Both comply with the standard. |
| DeviceComparison | Subject Device:SafeSource Direct BluePowder-Free Nitrile ExamGloves | Predicate Device:Medline Powder-Free LightBlue Nitrile Exam Gloves(K201390) | Comparison |
| Dimensions-Thickness | Complies with ASTM D6319-19Palm – 0.05 minimumFinger – 0.05 minimum | XL: 115 $\pm$ 10mmComplies with ASTM D6319-10Palm - 0.14Finger - 0.16Cuff - 0.12 | Similar- Bothcomply with thestandard. Cuffwas notmeasured onthe subjectdevice. |
| PhysicalProperties –Tensile Strength | Complies with ASTM D6319-19Tensile Strength:Before Aging $\geq$ 14 Mpa, minAfter Aging $\geq$ 14 Mpa, min | Complies with ASTM D6319-10Tensile Strength:Before Aging $\geq$ 17 Mpa, minAfter Aging $\geq$ 14 Mpa, min | Similar- Bothcomply with thestandard. |
| PhysicalProperties –Elongation | Elongation:Before Aging 500% MinAfter Aging 400% Min | Elongation:Before Aging 500% MinAfter Aging 400% Min | Identical |
| Freedom fromHoles | Complies with ASTM D6319-19and ASTM D5151-06 G-1, AQL 2.5 | Complies with ASTM D6319-10and ASTM D5151-06 G-1, AQL 2.5 | Identical |
| Residual Powder | Max. 0.42mg per glove | Max. 0.52mg per glove | Identical |
| Biocompatibility | ISO 10993-10ISO 10993-11Not a skin irritantNot a skin sensitizerNo clinical sign ofacute systemictoxicity | • ISO 10993-10: Primary SkinIrritation, not a skin irritant• ISO 10993-10: DermalSensitization, not a skinsensitizer• ISO 10993-11: No clinical signof acute systemic toxicity | Identical- Bothdevices are nota skin irritant orskin sensitizer.Both devicesshowed noclinical sign ofacute systemictoxicity |
| Sterility | Non-sterile | Non-sterile | Identical |
Table 1 – General Comparison
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Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
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Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
Non-Clinical Performance Data
Table 2 - Summary of Non-Clinical Performance Testing
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical DimensionsTest | Length (mm):S: ≥ 220M/L/XL: ≥ 230Width (mm):S: 80 ± 10M: 95 ± 10L: 110 ± 10XL: 120 ± 10Thickness (mm): | Length (mm):S: ≥ 220 / PassM/L/XL: ≥ 230 / PassWidth (mm):S: 82 – 85 / PassM: 95 – 97 / PassL: 103 – 107 / PassXL: 110 – 116 / PassThickness (mm): |
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Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
| Finger: ≥ 0.05Palm: ≥ 0.05 | Finger: 0.13 – 0.17 / PassPalm: 0.09 – 0.11 / Pass | ||||
|---|---|---|---|---|---|
| ASTM D5151 | Watertightness Testfor Detection of Holes | Meet the requirements of ASTMD5151 AQL 2.5 | S: 1/125 / PassM: 2/125 / PassL: 2/125 / PassXL: 4/125 / Pass | ||
| ASTM D6124 | Powder Content | Meet the requirements of ASTMD6124 < 2.0 mg | 0.4 mg / Pass | ||
| ASTM D412 | Physical Properties | Tensile Strength | ≥ 14 MPa | 14 – 19 MPa | |
| Before Aging | Ultimate Elongation | ≥ 500% | 515 – 540% | ||
| Meet the requirements of ASTM D412 AQL 4.0 | 1/13 / Pass | ||||
| After Aging | Tensile Strength | ≥ 14 MPa | 15 – 20 / Pass | ||
| Ultimate Elongation | ≥ 400% | 468 – 525 / Pass | |||
| ISO 10993-5 | Cytotoxicity | Non-In Vitro Cytotoxicity | Under conditions of thestudy, device extract iscytotoxic. | ||
| ISO 10993-11 | Acute Systemic Toxicity | Non-Acute Systemic Toxicity | Under conditions of thestudy, did not show acutesystemic toxicity in vivo. /Pass | ||
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of thestudy, not an irritant. / Pass | ||
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of thestudy, not a sensitizer. /Pass |
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Clinical Performance Testing
Clinical testing is not needed for this device.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, SafeSource Direct Blue Powder-Free Nitrile Exam Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K201390.
§ 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.