(45 days)
Not Found
No
The device is a physical examination glove and the summary describes its material properties and performance against chemical permeation, with no mention of AI or ML.
No
The device, an examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device described is a physical medical device (patient examination gloves) and does not involve any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Intended Use: The intended use of this device is "a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device used for protection during patient examination.
- Device Description: The device description reinforces that it is a "patient examination glove" worn on the hands for contamination prevention.
- Performance Studies and Metrics: The performance studies and key metrics listed relate to the physical properties, biocompatibility, and barrier function of the glove (e.g., watertightness, tensile strength, chemotherapy drug permeation). These are not diagnostic tests performed on patient samples.
The fact that the gloves were tested for chemotherapy drug permeation relates to their protective function as a barrier, not to their use in diagnosing a condition.
Therefore, this device is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data
- ASTM D6319 (Physical Dimensions Test):
- Length (mm):
- Acceptance Criteria: S: ≥ 220; M/L/XL: ≥ 230
- Results: S: ≥ 220 / Pass; M/L/XL: ≥ 230 / Pass
- Width (mm):
- Acceptance Criteria: S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10
- Results: S: 82 – 85 / Pass; M: 95 – 97 / Pass; L: 103 – 107 / Pass; XL: 110 – 116 / Pass
- Thickness (mm):
- Acceptance Criteria: Finger: ≥ 0.05; Palm: ≥ 0.05
- Results: Finger: 0.13 – 0.17 / Pass; Palm: 0.09 – 0.11 / Pass
- Length (mm):
- ASTM D5151 (Watertightness Test for Detection of Holes):
- Acceptance Criteria: Meet the requirements of ASTM D5151 AQL 2.5
- Results: S: 1/125 / Pass; M: 2/125 / Pass; L: 2/125 / Pass; XL: 4/125 / Pass
- ASTM D6124 (Powder Content):
- Acceptance Criteria: Meet the requirements of ASTM D6124
§ 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.
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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.
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.
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
2
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, LLC
200 St Nazaire Rd.
Broussard, LA 70518
Sponsor Contact: Justin Hollingsworth |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC
Founder/Principal Consultant
Powers Regulatory Consulting
Tel: 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
4
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.
5
Technological Characteristics
The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves has similar technological characteristics as the predicate device.
| Table 1 – General Comparison | |||
|---|---|---|---|
| Device | |||
| Comparison | Subject Device: | ||
| SafeSource Direct Blue | |||
| Powder-Free Nitrile Exam | |||
| Gloves | |||
| (K222898) | Predicate Device: | ||
| Medline Powder-Free Light | |||
| Blue Nitrile Exam Gloves | |||
| (K201390) | Comparison | ||
| Device | SafeSource Direct Blue | ||
| Powder-Free Nitrile Exam | |||
| Gloves | Medline Powder-Free Light | ||
| Blue Nitrile Exam Gloves | Not Applicable | ||
| Manufacturer | SafeSource Direct, LLC | Medline Industries, Inc. | Not Applicable |
| FDA Product | |||
| Code | LZA, LZC, OPJ | LZA, LZC | Identical |
| Regulation | |||
| Name | Non-powdered Patient | ||
| Examination | |||
| Glove, Specialty | Non-powdered Patient | ||
| Examination | |||
| Glove, Specialty | Identical | ||
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Intended Use/ | |||
| 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 |
- 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 | 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 - Standard Practice for
Assessment of Medical Gloves
to Permeation by
Chemotherapy Drugs.
Carmustine (BCNU) 3.3 mg/ml
25.3 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 | Identical with
the exception of
the Carmustine
and Thio-Tepa
breakthrough
times. |
| Device Comparison | Subject Device:
SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves | Predicate Device:
Medline Powder-Free Light
Blue Nitrile Exam Gloves
(K201390) | Comparison |
| | 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) 43.7 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. | 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 43.7 Minutes
Vincristine Sulfate (Oncovin) 43.7 mg/ml ≥ 240 Minutes
Please note that the following drugs have low permeation times:
Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes
Thio-Tepa 10.0 mg/ml 43.7 Minutes
Caution: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa
WARNING: 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 or
Powder-Free | Powder free | Powder Free | Identical |
| Dimensions-Length | Complies with ASTM D6319-19
240mm min. | Complies with ASTM D6319-10
240mm min. | Identical |
| Dimensions-Width | Complies with ASTM D6319-19
S: 80±10mm
M: 95±10mm
L: 110±10mm
XL: 120±10mm | Complies with ASTM D6319-10
XS: N/A
S: 85±10mm
M: 95±10mm
L: 105±10mm | Similar- Both comply with the standard. |
| Device
Comparison | Subject Device:
SafeSource Direct Blue
Powder-Free Nitrile Exam
Gloves | Predicate Device:
Medline Powder-Free Light
Blue Nitrile Exam Gloves
(K201390) | Comparison |
| Dimensions-
Thickness | Complies with ASTM D6319-19
Palm – 0.05 minimum
Finger – 0.05 minimum | XL: 115 $\pm$ 10mm
Complies with ASTM D6319-10
Palm - 0.14
Finger - 0.16
Cuff - 0.12 | Similar- Both
comply with the
standard. Cuff
was not
measured on
the subject
device. |
| Physical
Properties –
Tensile Strength | Complies with ASTM D6319-19
Tensile Strength:
Before Aging $\geq$ 14 Mpa, min
After Aging $\geq$ 14 Mpa, min | Complies with ASTM D6319-10
Tensile Strength:
Before Aging $\geq$ 17 Mpa, min
After Aging $\geq$ 14 Mpa, min | Similar- Both
comply with the
standard. |
| Physical
Properties –
Elongation | Elongation:
Before Aging 500% Min
After Aging 400% Min | Elongation:
Before Aging 500% Min
After Aging 400% Min | Identical |
| Freedom from
Holes | Complies with ASTM D6319-19
and ASTM D5151-06 G-1, AQL 2.5 | Complies with ASTM D6319-10
and ASTM D5151-06 G-1, AQL 2.5 | Identical |
| Residual Powder | Max. 0.42mg per glove | Max. 0.52mg per glove | Identical |
| Biocompatibility | ISO 10993-10
ISO 10993-11
Not a skin irritant
Not a skin sensitizer
No clinical sign of
acute systemic
toxicity | • ISO 10993-10: Primary Skin
Irritation, not a skin irritant
• ISO 10993-10: Dermal
Sensitization, not a skin
sensitizer
• ISO 10993-11: No clinical sign
of acute systemic toxicity | Identical- Both
devices are not
a skin irritant or
skin sensitizer.
Both devices
showed no
clinical sign of
acute systemic
toxicity |
| Sterility | Non-sterile | Non-sterile | Identical |
Table 1 – General Comparison
6
Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
7
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 Dimensions | ||
| Test | Length (mm): | ||
| S: ≥ 220 | |||
| M/L/XL: ≥ 230 | |||
| Width (mm): | |||
| S: 80 ± 10 | |||
| M: 95 ± 10 | |||
| L: 110 ± 10 | |||
| XL: 120 ± 10 | |||
| Thickness (mm): | Length (mm): | ||
| S: ≥ 220 / Pass | |||
| M/L/XL: ≥ 230 / Pass | |||
| Width (mm): | |||
| S: 82 – 85 / Pass | |||
| M: 95 – 97 / Pass | |||
| L: 103 – 107 / Pass | |||
| XL: 110 – 116 / Pass | |||
| Thickness (mm): |
8
Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
| | | | Finger: ≥ 0.05
Palm: ≥ 0.05 | 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