(30 days)
Not Found
No
The device description and performance studies focus on the physical properties, chemical resistance, and biocompatibility of a medical glove, with no mention of AI or ML technology.
No.
The device is described as a patient examination glove intended to prevent contamination between patient and examiner, not to provide therapy or treatment for a disease or condition.
No
This device is a patient examination glove, intended to prevent contamination between patient and examiner. Its function is to provide a barrier, not to diagnose any condition.
No
The device described is a physical examination glove, not a software-only medical device. The description focuses on material properties, physical dimensions, and resistance to chemical permeation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "patient examination glove... intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination or procedures.
- Function: The device's function is to provide a physical barrier. While it has been tested for resistance to certain chemicals (chemotherapy drugs and fentanyl), this testing relates to the glove's protective properties, not its use in an in vitro diagnostic procedure.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such examination of specimens.
The testing for chemotherapy drug and fentanyl permeation is relevant to the glove's safety and suitability for use in environments where these substances are present, but it does not change the fundamental nature of the device from a barrier to an IVD.
N/A
Intended Use / Indications for Use
This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times: Carmustine: 14.7 minutes Thiotepa: 13.6 minutes Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs and fentanyl is provided in blue. It meets all the requirements of ASTM D6319. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs as well as Fentanyl, per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. It can be available in 4 specifications: S, M, L and XL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
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 tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
- ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
Key Results: All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accepted criteria for tests include:
Dimensions: Length: greater than or equal to 220mm (S, M), greater than or equal to 230mm (L, XL), Width: 70±10 mm (S), 80±10mm (M), 95±10mm (L), 110±10mm (XL), 120±10mm (XXL).
Thickness: greater than or equal to 0.05mm for finger and palm.
Physical properties: Before Aging: Tensile Strength greater than or equal to 14MPa, Ultimate Elongation greater than or equal to 500%. After Aging: Tensile Strength greater than or equal to 14MPa, Ultimate Elongation greater than or equal to 400%.
Freedom from holes: Shall comply with freedom from holes (AQL = 2.5) when tested in accordance with ASTM D5151.
Powder-free Residue: Have a powder residue limit of 2.0 mg in accordance with ASTM D6124.
Irritation: Non-irritating.
Sensitization: Non-sensitizing.
Resistance to permeation by Fentanyl: No breakthrough when tested for permeation with Fentanyl in accordance with ASTM D6978.
Resistance to Permeation by Chemotherapy Drugs: Covered in predicate device 510(k) K171378.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
January 27, 2023
Semperit Investments Asia PTE. LTD. % Jay Mansour Regulatory Consultant / Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075
Re: K223903
Trade/Device Name: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: December 27, 2022 Received: December 28, 2022
Dear Jay Mansour:
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 medical devices and radiation-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 G
For Bifeng Qian 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223903
Device Name Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE Indications for Use (Describe) This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is: Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes Please note that the following drugs have extremely low permeation times:
Carmustine: 14.7 minutes Thiotepa: 13.6 minutes
Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA
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
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4
K223903- 510(k) summary
I Submitter
Device submitter: SEMPERIT INVESTMENTS ASIA PTE. LTD. 8 Jurong Town Hall Road, #29-03 To 06 The JTC Summit Singapore 609434
- Contact person: Jay Mansour Mansour Consulting LLC Regulatory consultant Phone (678) 908-8180 Email jay@mansourconsulting.com
Date of preparation: January 27, 2023
II Proposed device
| 510(k) Number: | K223903 |
|---|---|
| Trade/Device Name: | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl |
| SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104) | |
| X-LARGE SIZE (NGPF105) | |
| Regulation number: | 21 CFR 880.6250 |
| Regulation name: | Non-powdered Patient Examination Glove |
| Regulatory class: | Class I |
| Product code: | LZA (primary), LZC, OPJ, QDO |
| Review panel: | General Hospital |
III Predicate devices
| 510(k) Number: | K171378 |
|---|---|
| Trade/Device name: | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs |
| Regulation number: | 21 CFR 880.6250 |
| Regulation name: | Non-powdered Patient Examination Glove |
| Regulatory class: | Class I |
5
Product code: LZA (primary), LZC SEMPERIT INVESTMENTS ASIA PTE. LTD. Manufacturer:
IV Device description
The Non-Sterile, Single use, Powder-free Examination glove, Blue, tested for use with Chemotherapy Drugs and fentanyl is provided in blue. It meets all the requirements of ASTM D6319. It is a medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves were tested for use with chemotherapy drugs as well as Fentanyl, per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug. It can be available in 4 specifications: S, M, L and XL.
V Indications for use
This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The tested chemotherapy drugs are:
Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes.
Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes
Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Etoposide (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Fluorouracil (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes lfosfamide (50.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Methotrexate (25.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitomycin C (0.5 mg/ml). Permeation time: no breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml). Permeation time: no breakthrough up to 240 minutes Thiotepa (10.0 mg/ml). Permeation time: Thiotepa has extremely low permeation times of 13.6 minutes
Vincristine Sulfate (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes The tested Opioid is:
Fentanyl Citrate Injection (100mcg/2mL). Permeation: no breakthrough up to 240 minutes
Please note that the following drugs have extremely low permeation times:
Carmustine: 14.7 minutes
Thiotepa: 13.6 minutes
Warning: DO NOT USE WITH CARMUSTINE OR THIOTEPA
6
VI Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
-
ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves
-
ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves
-
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ISO 10993-10: 2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
7
| Test
| method | Purpose | Acceptance Criteria | Result | |
|---|---|---|---|---|
| ASTM | ||||
| D6319 | Dimensions | Extra-Small | Length: ≥220mm; | |
| Width: 70±10 mm | ||||
| Small | Length: ≥220mm; | |||
| Width: 80±10mm | ||||
| Medium | Length: ≥230mm; | |||
| Width: 95±10mm | Pass | |||
| Large | Length: ≥230mm; | |||
| Width: 110±10mm | ||||
| Extra- Large | Length: ≥230mm; | |||
| Width: 120±10mm | ||||
| Thickness (mm): | ||||
| Finger: ≥0.05 | ||||
| Palm: ≥0.05 | Pass | |||
| Physical properties | Before | |||
| Aging | Tensile | |||
| Strength ≥14MPa | ||||
| Ultimate | ||||
| Elongation ≥500% | Pass | |||
| After | ||||
| Aging | Tensile | |||
| Strength ≥14MPa | ||||
| Ultimate | ||||
| Elongation ≥400% | Pass | |||
| ASTM | ||||
| D5151 | Freedom from holes | Shall comply with freedom from holes (AQL = 2.5) | ||
| when tested in accordance with ASTM D5151. | Pass | |||
| ASTM | ||||
| D6124 | Powder-free Residue | Have a powder residue limit of 2.0 mg in | ||
| accordance with ASTM D6124. | Pass | |||
| ISO | ||||
| 10993-10 | To determine if the | |||
| finished device | ||||
| material is an irritant. | Non-irritating | Under the conditions of | ||
| the study not an irritant/ | ||||
| Pass | ||||
| ISO | ||||
| 10993-10 | To determine if the | |||
| finished device | ||||
| material is a sensitizer. | Non-sensitizing | Under conditions of the | ||
| study, not a sensitizer. / | ||||
| Pass | ||||
| Resistance to | ||||
| permeation by | ||||
| Fentanyl | No breakthrough when tested for permeation with | |||
| Fentanyl in accordance with ASTM D6978. | Pass | |||
| ASTM | ||||
| D6978 | Resistance to | |||
| Permeation by | ||||
| Chemotherapy Drugs | Covered in predicate device 510(k) K171378 for | |||
| Carmustine (BCNU) (3.3 mg/ml) | ||||
| Cisplatin (1.0 mg/ml) | ||||
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | ||||
| Cytarabine (100 mg/ml) | ||||
| Dacarbazine (DTIC) (10.0 mg/ml) | ||||
| Doxorubicin Hydrochloride (2.0 mg/ml) | ||||
| Etoposide (20.0 mg/ml) | ||||
| Fluorouracil (50.0 mg/ml) | ||||
| Ifosfamide (50.0 mg/ml) | ||||
| Methotrexate (25.0 mg/ml) | ||||
| Mitomycin C (0.5 mg/ml) | ||||
| Mitoxantrone (2.0 mg/ml) | ||||
| Paclitaxel (Taxol) (6.0 mg/ml) | Pass |
Table 1 Summary of Non-Clinical Performance Testing
8
| | Vincristine Sulfate (1.0 mg/ml)
Thiotepa (10.0 mg/ml) | |
|--|----------------------------------------------------------|--|
| | | |
9
VII Clinical Test Conclusion
No clinical study is included in this submission.
VIII Summary of Technological characteristics
| Subject device | Predicate device | Comments | |
|---|---|---|---|
| Manufacturer | SEMPERIT INVESTMENTS ASIA PTE. LTD. | SEMPERIT INVESTMENTS ASIA PTE. LTD. | N/A |
| 510(k) number | TBD | K171378 | N/A |
| Device trade or | |||
| proprietary name | Non-Sterile, Single use, Powder-free | ||
| examination glove, Blue, tested for use | |||
| with Chemotherapy drugs and fentanyl | Non-Sterile, Powder-free Examination | ||
| glove, Blue, tested for use with | |||
| Chemotherapy Drugs | Different: except the addition of Fentanyl for | ||
| subject device, it is identical | |||
| Device Classification | |||
| Name/ Regulation number | Patient Examination Glove | ||
| 21 CFR Part 880.6250 | Patient Examination Glove | ||
| 21 CFR Part 880.6250 | Identical | ||
| Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC | Different: added two product codes |
| Indications for use | This device is an ambidextrous patient | ||
| examination glove that is a non-sterile, | |||
| single use, disposable device intended | |||
| for medical purposes, worn on the | |||
| examiner's hand or finger to prevent | |||
| contamination between patient and | |||
| examiner. | |||
| The tested chemotherapy drugs are: | |||
| Carmustine (BCNU) (3.3 mg/ml). | |||
| Permeation time: Carmustine (BCNU) | |||
| has extremely low permeation times of | |||
| 14.7 minutes. | |||
| Cisplatin (1.0 mg/ml). Permeation time: | |||
| no breakthrough up to 240 minutes | |||
| Cyclophosphamide (Cytoxan) (20.0 mg/ | |||
| ml). Permeation time: no breakthrough | |||
| up to 240 minutes Cytarabine (100 mg/ | |||
| ml). Permeation time: no breakthrough | |||
| up to 240 minutes Dacarbazine (DTIC) | |||
| (10.0 mg/ml). Permeation time: no | |||
| breakthrough up to 240 minutes | |||
| Doxorubicin Hydrochloride (2.0 mg/ml). | |||
| Permeation time: no breakthrough up to | |||
| 240 minutes | |||
| Etoposide (20.0 mg/ml). Permeation | |||
| time: no breakthrough up to 240 | |||
| minutes Fluorouracil (50.0 mg/ml). | |||
| Permeation time: no breakthrough up to | |||
| This device is an ambidextrous patient | |||
| examination glove that is a non-sterile, | |||
| single use, disposable device intended | |||
| for medical purposes, worn on the | |||
| examiner's hand or finger to prevent | |||
| contamination between patient and | |||
| examiner. The tested chemotherapy | |||
| drugs are: | |||
| Carmustine (BCNU) (3.3 mg/ml). | |||
| Permeation time: Carmustine (BCNU) has | |||
| extremely low permeation times of 14.7 | |||
| minutes. | |||
| Cisplatin (1.0 mg/ml). Permeation time: | |||
| no breakthrough up to 240 minutes | |||
| Cyclophosphamide (Cytoxan) (20.0 | |||
| mg/ml). Permeation time: no | |||
| breakthrough up to 240 minutes | |||
| Cytarabine (100 mg/ml). Permeation | |||
| time: no breakthrough up to 240 minutes | |||
| Dacarbazine (DTIC) (10.0 mg/ml). | |||
| Permeation time: no breakthrough up to | |||
| 240 minutes | |||
| Doxorubicin Hydrochloride (2.0 mg/ml). | |||
| Permeation time: no breakthrough up to | |||
| 240 minutes | |||
| Etoposide (20.0 mg/ml). Permeation | |||
| time: no breakthrough up to 240 minutes | |||
| Fluorouracil (50.0 mg/ml). Permeation | |||
| time: no breakthrough up to 240 minutes | |||
| Ifosfamide (50.0 mg/ml). Permeation | |||
| time: no breakthrough up to 240 minutes | |||
| Methotrexate (25.0 mg/ml). Permeation | |||
| time: no breakthrough up to 240 minutes | |||
| Mitomycin C (0.5 mg/ml). Permeation | |||
| time: no breakthrough up to 240 minutes | |||
| Mitoxantrone (2.0 mg/ml). Permeation | |||
| time: no breakthrough up to 240 minutes | |||
| Paclitaxel (Taxol) (6.0 mg/ml). | |||
| Permeation time: no breakthrough up to | |||
| 240 minutes | |||
| Thiotepa (10.0 mg/ml). Permeation time: | |||
| Thiotepa has extremely low permeation | |||
| times of 13.6 minutes | |||
| Vincristine Sulfate (1.0 mg/ml). | |||
| Permeation time: no Breakthrough up to | |||
| 240 minutes. | |||
| DO NOT USE WITH CARMUSTINE OR | |||
| THIOTEPA | Different | ||
| Subject device includes Fentanyl, while | |||
| predicate device does not. Other than for | |||
| Fentanyl, the indications for use are identical. | |||
| Note: Adding the Fentanyl to the indication | |||
| does not affect the intended use. The device's | |||
| intended use is it would be worn on the hand | |||
| for medical purposes to provide a barrier | |||
| against potentially infectious materials and | |||
| other contaminants. Therefore, there are no | |||
| differences to the intended therapeutic, | |||
| diagnostic, prosthetic, or surgical use of the | |||
| device, and therefore the change in the | |||
| indication for use (by adding Fentanyl) does | |||
| not affect the safety and effectiveness of the | |||
| device when used as labeled. | |||
| Materials | Nitrile | Nitrile | Identical |
| Standards used | 1. ISO 10993-10 |
- ASTM D6319-19
- ASTM D6124-06 (reapproved 2017)
- ASTM D5151-19
- ASTM D6978-05 (reapproved 2019)
- ISO 2859-1
- ASTM D412-16e1
- ASTM D3767-03 (2020)
- ASTM D573-04 (2019) | 1. ISO 10993-10
- ASTM D6319-10 (reapproved 21015)
- ASTM D6124-06 (2011)
- ASTM D5151-06
- ASTM D6978-05 (re-approved 2013)
- ISO 2859-1
- ASTM D412-16
- ASTM D3767-03 (2014)
- ASTM D573-04 (2015) | Identical, with justification provided below, following the same numbering sequence:
- See biocompatibility below
- The changes did not affect product design, production and compliance
(1st change: section 1.5. 2nd change: adding calculation options instead of actual cutting. 3rd change: limitation on accelerated aging option based on natural aging. 4th change: size XXL is introduced in the revised standard BUT it is NOT added in this submission). Recognition number is updated from 6-244 to 6-446 |
| | | | 3. No changes in the standard.
Recognition number 6-178 remains the same. |
| | | | 4. The changes did not affect product design, production and compliance
(1st change: section 1.7. 2nd change: temperature of the water leak test). Recognition number is updated from 6-175 to 6-424 |
| | | | 5. No change in the standard. Recognition number 6-147 remains the same |
| | | | 6. No change in the standard. Recognition number was updated from 5-62 to 5-88 |
| | | | 7. No changes in the standard. Version D412-16 was accepted in 510k submissions without recognition number. D412-16e1 is now recognized under recognition number 8-559. |
| | | | 8. No changes in the standard. Standard accepted in 510k submissions but still not having a recognition number. |
| | | | 9. No changes in the standard. Standard accepted in 510k submissions but still not having a recognition number. |
| Non-Sterile, Single Use, disposable | Yes | Yes | Identical |
| Packaging | Packed in Dispenser Boxes | Packed in Dispenser Boxes | Identical |
| Labeling Features | Non-Sterile
Powder Free
Examination Gloves
Ambidextrous, by Size
Single use only
Device Color
Manufactured for:
Lot Number:
Quantity by Weight
Made in Malaysia | Non-Sterile
Powder Free
Examination Gloves
Ambidextrous, by Size
Single use only
Device Color
Manufactured for:
Lot Number:
Quantity by Weight
Made in Malaysia | Identical |
| Labeling Claim | Tested for Use with Chemotherapy Drugs and Fentanyl | Tested for Use with Chemotherapy Drugs | Identical except for the addition of Fentanyl, which is the subject of this submission |
| Biocompatibility | Sensitization and irritation compliant as
per ISO 10993-10 | Sensitization and irritation compliant as
per ISO 10993-10 | Identical based on recognition number 2-174
covering sensitization and irritation in the
same standard |
10
11
12
13
IX Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission K223903, Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs , cleared under 510(k) K171378.