(26 days)
An examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. chemotherapy drugs; Gastric Acid; Xylazine; Fentanyl
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
This document is a 510(k) clearance letter for a medical device: "Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl". This type of device is a physical barrier and does not involve AI or imaging analysis, which are the typical contexts for the detailed acceptance criteria and study designs you've requested.
Therefore, many of the specific questions you've asked, such as those related to AI algorithm performance (e.g., sample size for training set, number of experts for ground truth, MRMC studies) are not applicable to this device.
However, I can extract the closest analogous information from the provided text about the device's performance against its stated "Indications for Use," which serves as its functional acceptance criteria.
Understanding the Device and its "Acceptance Criteria":
The device is a medical glove. Its primary "acceptance criteria" are related to its ability to prevent permeation by various substances, specifically:
- 60 chemotherapy drugs
- Gastric Acid
- Xylazine
- Fentanyl Citrate
The reported "device performance" is measured by the "Minimum Breakthrough Detection Time (Min.)" when tested according to ASTM D6978-05. The acceptance criterion implied for most tested substances is "no breakthrough detected up to 240 minutes" (i.e., >240 minutes). For two specific drugs, Carmustine and Thiotepa, the breakthrough times are explicitly lower (11 minutes and 39 minutes, respectively), and the label includes a warning that these should not be used with these drugs.
Here's the information parsed from the document, addressing your questions where applicable, and stating "Not Applicable" (N/A) for those that don't fit the context of a physical barrier device or an AI/imaging study:
1. A table of acceptance criteria and the reported device performance
For most substances, the implied acceptance criterion is "no breakthrough detected up to 240 minutes". The reported performance generally meets this, with specific exceptions noted.
| Substance/Chemotherapy Drug | Concentration (mg/ml or other) | Acceptance Criterion (Based on typical performance) | Reported Device Performance (Minimum Breakthrough Detection Time - Min.) |
|---|---|---|---|
| Most Chemotherapy Drugs (58 out of 60 listed) | Varies (e.g., Amethopterin 25.0, Bleomycin Sulfate 15.0) | >240 minutes breakthrough time | >240 |
| Carmustine | 3.3 | N/A (specific warning) | 11.0 |
| Thiotepa | 10.0 | N/A (specific warning) | 39.0 |
| Gastric Acid | Not specified (Simulated) | >240 minutes breakthrough time | >240 (no breakthrough detected up to 240 minutes) |
| Xylazine | 100 mg/ml | >240 minutes breakthrough time | >240 (no breakthrough detected up to 240 minutes) |
| Fentanyl Citrate | 100mcg/2ml | >240 minutes breakthrough time | >240 (no breakthrough detected up to 240 minutes) |
Note: The "acceptance criterion" column for Carmustine and Thiotepa is marked N/A because the device performance is clearly below the general threshold of >240 minutes, and instead, the clearance document acknowledges this lower performance and specifies a warning against their use. This means the device is cleared despite not meeting the >240 min criterion for these two specific chemicals, but with a critical warning to users.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The testing was conducted according to ASTM D6978-05, which would stipulate the required sample sizes for such tests, but the specific number used for this device is not reported.
- Data Provenance: The manufacturer is "GMP Medicare Sdn. Bhd." located in Malaysia. The testing methodology (ASTM D6978-05) is an international standard. Whether the testing was performed in Malaysia or another country is not specified, nor is whether the data is retrospective or prospective, though performance testing for device clearance is typically prospective by nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This device is a physical barrier. "Ground truth" in this context is established by objective laboratory testing (permeation time using analytical methods), not by human expert interpretation (like radiologists for medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human annotators/experts, typically in medical imaging or clinical trials. The "test set" here refers to physical samples of gloves subjected to a standardized chemical permeation test. The results are quantitative and objectively measured.
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
- N/A. This is a physical device, not an AI-assisted diagnostic tool. No human "readers" or AI assistance are involved in its primary function or testing for this clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Objective laboratory measurement/Chemical Permeation Testing: The "ground truth" for this device's performance is the direct measurement of breakthrough time using the standardized ASTM D6978-05 method. This involves analytical detection of the permeating substance on the non-contact side of the glove.
8. The sample size for the training set
- N/A. This is a physical device. There is no "training set" in the context of machine learning. Design and development of the glove material (e.g., nitrile composition) would involve material science and manufacturing processes, but not a machine learning training set.
9. How the ground truth for the training set was established
- N/A. As above, no training set for an algorithm is involved.
FDA 510(k) Clearance Letter
Page 1
April 23, 2025
GMP Medicare Sdn. Bhd.
Ummi Salmah Othman
Regulatory Affairs Assistant Manager
Lot/PT 64593, Jalan Dahlia/KU8,
Kawasan Perindustrian Meru Timur
Klang, Selangor 41050
Malaysia
Re: K250944
Trade/Device Name: Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
Regulation Number: 21 CFR 880.6250
Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved
Product Code: LZA, LZC, QDO, OPJ
Dated: March 24, 2025
Received: March 28, 2025
Dear Ummi Salmah Othman:
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 (the 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 available 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
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K250944 - Ummi Salmah Othman Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
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K250944 - Ummi Salmah Othman Page 3
(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-devices/device-advice-comprehensive-regulatory-assistance/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 GUAN -S
For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K250944
Please provide the device trade name(s).
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl
Please provide your Indications for Use below.
An examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs with Gastric Acid, Xylazine and Fentanyl Citrate in accordance with ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| No | Chemotherapy Drugs | Concentration (mg/ml) | Minimum Breakthrough Detection Time (Min.) |
|---|---|---|---|
| 1 | Amethopterin | 25.0 | >240 |
| 2 | Azacitidine (Vidaza) | 25.0 | >240 |
| 3 | Bendamustine HCl | 5.0 | >240 |
| 4 | Bleomycin Sulfate | 15.0 | >240 |
| 5 | Busulfan | 6.0 | >240 |
| 6 | Capecitabine | 26.0 | >240 |
| 7 | Carboplatin | 10.0 | >240 |
| 8 | Carfilzomib | 2.0 | >240 |
| 9 | Carmustine | 3.3 | 11.0 |
| 10 | Cetuximab (Erbitux) | 2.0 | >240 |
| 11 | Chloroquine | 50.0 | >240 |
| 12 | Cisplatin | 1.0 | >240 |
| 13 | Cladribine | 1.0 | >240 |
| 14 | Cyclophosphamide | 20.0 | >240 |
| 15 | Cyclosporin A | 100.0 | >240 |
| 16 | Cytarabine | 100.0 | >240 |
| 17 | Cytovene | 10.0 | >240 |
| 18 | Dacarbazine | 10.0 | >240 |
| 19 | Dactinomycin | 0.5 | >240 |
| 20 | Daunorubin HCl | 5.0 | >240 |
| 21 | Decitabine | 5.0 | >240 |
| 22 | Docetaxel | 10.0 | >240 |
| 23 | Doxorubicin Hydrochloride | 2.0 | >240 |
| 24 | Ellence | 2.0 | >240 |
| 25 | Eribulin Mesylate | 0.5 | >240 |
| 26 | Etoposide | 20.0 | >240 |
| 27 | Fludarabine | 25.0 | >240 |
| 28 | Fluorouracil | 50.0 | >240 |
| 29 | Fulvestrant | 50.0 | >240 |
| 30 | Gemcitabine | 38.0 | >240 |
| 31 | Idarubicin | 1.0 | >240 |
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, with Page 7 of 28
Page 5
| 32 | Ifosfamide | 50.0 | >240 |
| 33 | Irinotecan | 20.0 | >240 |
| 34 | Ixabepilone | 2.0 | >240 |
| 35 | Leuprolide Acetate | 5.0 | >240 |
| 36 | Mechlorethamine | 1.0 | >240 |
| 37 | Melphalan | 5.0 | >240 |
| 38 | MESNA | 100.0 | >240 |
| 39 | Methotrexate | 25.0 | >240 |
| 40 | Mitomycin C | 0.5 | >240 |
| 41 | Mitoxantrone | 2.0 | >240 |
| 42 | Oxaliplatin | 5.0 | >240 |
| 43 | Paclitaxel | 6.0 | >240 |
| 44 | Pemetrexed | 25.0 | >240 |
| 45 | Pertuzumab | 30.0 | >240 |
| 46 | Propofol | 10.0 | >240 |
| 47 | Raltitrexed | 0.5 | >240 |
| 48 | Retrovir | 10.0 | >240 |
| 49 | Rituximab | 10.0 | >240 |
| 50 | Temsirolimus | 25.0 | >240 |
| 51 | Thiotepa | 10.0 | 39.0 |
| 52 | Topotecan | 1.0 | >240 |
| 53 | Trastuzumab | 21.0 | >240 |
| 54 | Triclosan | 1.0 | >240 |
| 55 | Trisenox | 1.0 | >240 |
| 56 | Velcade (Bortezomib) | 1.0 | >240 |
| 57 | Vincristine Sulfate | 1.0 | >240 |
| 58 | Vinblastine Sulfate | 1.0 | >240 |
| 59 | Vinorelbine | 10.0 | >240 |
| 60 | Zoledronic Acid | 0.8 | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 11 minutes and 39 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Gastric Acid - Under the testing conditions of ASTM D6978-05, Simulated Gastric Acid was found to have no breakthrough detected up to 240 minutes.
Xylazine - Under the testing conditions of ASTM D6978-05, Xylazine HCl Injection (100 mg/ml) was found to have no breakthrough detected up to 240 minutes.
Fentanyl - Under the testing conditions of ASTM D6978-05, Fentanyl Citrate Injection (100mcg/2ml) was found to have no breakthrough detected up to 240 minutes.
Please select the types of uses (select one or both, as applicable).
- Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, with Page 8 of 28
§ 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.